HealthyPhase 1NCT05285137
Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
A Phase 1 study testing CD388 Injection in people with Healthy, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
Trial summary
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in the muscle or under the skin. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CD388 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2022to 27 Oct 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Males and females 18 to 65 years of age, inclusive.
- A female subject must meet one of the following criteria:
- If of childbearing potential - agrees to use a highly effective, preferably user-independent method of contraception (failure rate of <1 percent per year when used consistently and correctly) for at least 30 days prior to screening and agrees to remain on a highly effective method until 205 days after last dose of study medication. Examples of highly-effective methods of contraception include: abstinence from heterosexual intercourse; hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch); intrauterine device (with or without hormones); or a double barrier method (e.g., condom and spermicide).
- If a female of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by follicle-stimulating hormone (FSH) levels (≥40 milli-International units [mIU]/milliliter [mL]).
- A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before the first dose of study drug.
Show all 16Show fewer
- A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and until at least 205 days after the last dose of the study medication.
- Good health and without signs or symptoms of current illness.
- Normal clinical examination, including:
- No physical examination findings that an Investigator determines would interfere with interpretation of study results.
- Screening ECG without clinically significant abnormalities.
- Creatinine clearance (CrCL) ≥80 mL/minute as calculated using the Cockcroft-Gault equation.
- Negative urine screen for drugs of abuse and alcohol at screening and Day -1.
- Body mass index (BMI; weight in kilograms [kg] divided by height in meters [m] squared) between 18.0 and 32.0 kg/m^2, inclusive.
- Willing to refrain from strenuous physical activity that could cause muscle aches or injury, including contact sports, at any time from screening through 30 days after any dose of study drug.
- Subject has adequate venous access for blood collection.
Who cannot join
- History of any hypersensitivity or allergic reaction to zanamivir or other neuraminidase inhibitors (i.e., laninamivir, oseltamivir, peramivir), or to excipients of the CD388 Injection drug formulation; or history of drug-induced exfoliative skin disorders (e.g., Stevens-Johnson syndrome [SJS], erythema multiforme, or toxic epidermal necrolysis [TEN]).
- History of any of the following:
- Allergies, anaphylaxis, skin rashes (foods such as milk, eggs, medications, vaccines, polyethylene glycol [PEG], etc.).
- Chronic immune-mediated disease, positive first-degree family history of autoimmune diseases.
- Atopic dermatitis or psoriasis.
- Bleeding disorder.
Show all 33Show fewer
- Psychiatric condition, seizures, hallucinations, anxiety, depression, or treatment for mental conditions.
- Migraines.
- Syncope, or vasovagal syndrome with injections or blood draws.
- Cardiac arrhythmia.
- Subjects with one or more of the following laboratory abnormalities at screening as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events v2.1 (DAIDS 2017):
- Serum creatinine, Grade ≥1 (≥1.1 × upper limit of normal [ULN])
- Pancreatic amylase or lipase, Grade ≥2 (≥1.5 × ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), Grade ≥1 (≥1.25 × ULN)
- Total bilirubin, Grade ≥1 (≥1.1 × ULN)
- Any other toxicity Grade ≥2, except for Grade 2 elevations of triglycerides, low density lipoprotein cholesterol, and/or total cholesterol.
- Any other laboratory abnormality considered to be clinically significant by the Investigator.
- Note: Retesting of abnormal laboratory values that may lead to exclusion will be allowed once without prior asking approval from the Sponsor. Retesting will take place during a scheduled or unscheduled visit during screening. Subjects with a normal value at retest may be included.
- Alcohol or drug addiction in the past 2 years.
- Experiencing symptoms of acute illness or chronic disease within 14 days prior to check-in to the clinical research unit (CRU).
- At screening, a positive result for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.
- A positive result at screening or CRU check-in for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by polymerase chain reaction (PCR). Beginning with Protocol Amendment 2, antigen testing may be used if PCR is not available.
- Unwilling to comply with local health policy effective at the time regarding coronavirus disease 2019 (COVID-19).*
- Women who are pregnant or nursing.
- Received any over-the-counter (OTC) medications or nutritional supplements within 7 days, or any prescription medications within 14 days or <5 half-lives prior to dosing.
- Current nicotine user or has quit habitual nicotine use in the 30 days prior to screening.
- Received any vaccines or immunoglobulins within 28 days prior to dosing (90 days in case of intravenous immunoglobulin [IVIg] or biologics, or 14 days for COVID-19 vaccine).**
- Donated blood (within 56 days of screening) or plasma (within 7 days of screening) or experienced significant blood loss or significant blood draw when participating in non-interventional clinical trials within 60 days prior to dosing.
- Received a blood transfusion within 28 days prior to dosing.
- Received any biologics within 90 days prior to dosing. Previous participation in another study within 30 days or 5 half-lives of the study drug, whichever is longer, prior to screening; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable.
- The PI considers that the volunteer should not participate in the study.
- () Full COVID-19 vaccination prior to participation is strongly recommended.
- () In the event a subject chooses to receive one of the two 2-dose approved or emergency-use-authorized COVID 19 vaccines (Comirnaty® [Pfizer], Spikevax™ [Moderna]) in the interval between two CRU stays (Cohort 2A/2B or Cohort 3A/3B), flexibility in timing of the second CRU stay should be applied, to allow appropriate receipt of the second vaccine dosage or booster (based on the respective vaccine label) + 14 days, to minimize risk of confounding findings/observations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in the muscle or under the skin.
Read the detailed description
A Phase 1, single-center, prospective, randomized, double-blind, single-dose and repeat single-dose, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD388 Injection, as compared to saline placebo, when dosed either by intramuscular (IM) or subcutaneous (SQ) administration to healthy adult subjects.
- Conditions
- Healthy
- Being tested
- CD388 Injection, Saline placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD388 InjectionCombination product
CD388 liquid for injection
Saline placeboDrug
Sterile normal saline for injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A (sentinel) | Experimental | Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 1A (main) | Experimental | Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 1B (sentinel) | Experimental | Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 1B (main) | Experimental | Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 2A (sentinel) | Experimental | Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 2A (main) | Experimental | Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 2B (sentinel) | Experimental | Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 2B (main) | Experimental | Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 3A (sentinel) | Experimental | High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 3A (main) | Experimental | High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 3B (sentinel) | Experimental | High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 3B (main) | Experimental | High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 4B (sentinel) | Experimental | Highest dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
| Cohort 4B (main) | Experimental | Highest dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection Receives: Combination Product: CD388 Injection; Drug: Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Number of participants with at least one TEAE, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Measured: Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)
Severity of TEAEs After a Single Dose of CD388
Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Measured: Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)
Secondary outcomes (30)
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Apparent Clearance (CL/F) Following a Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following the first single dose of CD388 administered by either IM or SQ injection.
Measured: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
Measured: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388
Number of participants with at least one TEAE, including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.
Measured: Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)
Severity of TEAEs After a Repeated Single Dose of CD388
Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.
Measured: Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start14 Mar 2022
- Primary completion27 Oct 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Ozlem Equils, MD, Study director, Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Debra J Kelsh, MD, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285137
- Sponsor's protocol ID
- CD388.IM.SQ.1.01
- Status last verified
- Feb 2025
- First submitted
- 8 Mar 2022
- Last updated
- 27 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05285137
- Acronym / sponsor ID
- CD388.IM.SQ.1.01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Collaborators
- Janssen Pharmaceuticals
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 27 Oct 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 17 Mar 2022 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in the muscle or under the skin.
Detailed description
A Phase 1, single-center, prospective, randomized, double-blind, single-dose and repeat single-dose, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD388 Injection, as compared to saline placebo, when dosed either by intramuscular (IM) or subcutaneous (SQ) administration to healthy adult subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A (sentinel) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboLow dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection |
| Cohort 1A (main) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboLow dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection |
| Cohort 1B (sentinel) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboLow dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection |
| Cohort 1B (main) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboLow dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection |
| Cohort 2A (sentinel) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboMid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 2A (main) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboMid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 2B (sentinel) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboMid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 2B (main) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboMid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 3A (sentinel) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboHigh dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 3A (main) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboHigh dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 3B (sentinel) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboHigh dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 3B (main) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboHigh dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose |
| Cohort 4B (sentinel) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboHighest dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection |
| Cohort 4B (main) | Experimental | Combination Product: CD388 Injection, Drug: Saline placeboHighest dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Willing and able to provide written informed consent.
- Males and females 18 to 65 years of age, inclusive.
- A female subject must meet one of the following criteria:
- A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before the first dose of study drug.
- A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and until at least 205 days after the last dose of the study medication.
Key exclusion criteria (33 listed)
- History of any hypersensitivity or allergic reaction to zanamivir or other neuraminidase inhibitors (i.e., laninamivir, oseltamivir, peramivir), or to excipients of the CD388 Injection drug formulation; or history of drug-induced exfoliative skin disorders (e.g., Stevens-Johnson syndrome [SJS], erythema multiforme, or toxic epidermal necrolysis [TEN]).
- History of any of the following:
- Subjects with one or more of the following laboratory abnormalities at screening as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events v2.1 (DAIDS 2017):
- Note: Retesting of abnormal laboratory values that may lead to exclusion will be allowed once without prior asking approval from the Sponsor. Retesting will take place during a scheduled or unscheduled visit during screening. Subjects with a normal value at retest may be included.
- Alcohol or drug addiction in the past 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD388 InjectionCD388 liquid for injection | Combination product | Cohort 1A (main), Cohort 1A (sentinel), Cohort 1B (main), Cohort 1B (sentinel), Cohort 2A (main), Cohort 2A (sentinel), Cohort 2B (main), Cohort 2B (sentinel), Cohort 3A (main), Cohort 3A (sentinel), Cohort 3B (main), Cohort 3B (sentinel), Cohort 4B (main), Cohort 4B (sentinel) |
| Saline placeboSterile normal saline for injection | Drug | Cohort 1A (main), Cohort 1A (sentinel), Cohort 1B (main), Cohort 1B (sentinel), Cohort 2A (main), Cohort 2A (sentinel), Cohort 2B (main), Cohort 2B (sentinel), Cohort 3A (main), Cohort 3A (sentinel), Cohort 3B (main), Cohort 3B (sentinel), Cohort 4B (main), Cohort 4B (sentinel) |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Time frame: Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)
Number of participants with at least one TEAE, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Severity of TEAEs After a Single Dose of CD388
Time frame: Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)
Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
30 secondary outcomes
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Apparent Clearance (CL/F) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
Time frame: Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
Time frame: At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388
Time frame: Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)
Severity of TEAEs After a Repeated Single Dose of CD388
Time frame: Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozlem Equils, MD study director
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Debra J Kelsh, MD principal investigator
Altasciences Company Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CD388 Injection in people with Healthy, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388 (time frame: Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.