HealthyPhase 1NCT05642546
First-in-Human (FIH) Clinical Study of NM8074 in Healthy Adult Volunteers
A Phase 1 study testing NM8074 in people with Healthy, run by NovelMed Therapeutics at 1 site in United States.
Trial summary
This is a Phase 1 randomized, double-blind, placebo-controlled, single administration, sequential cohort with sentinel dosing, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NM8074
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2020to 15 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or Female subjects ≥18 years to ≤60 years of age, inclusive
- Body mass index (BMI) between 18 kg/m2 and 32 kg/m2, inclusive and weigh at least 50 kg
- QT interval (Fridericia's correction [QTcF]); QTcF ≤ 450 msec for males and ≤ 470 msec for females at Screening and prior to dosing on Admittance Day -1
- Willing and able to give signed Informed Consent and comply with the study visit schedule
- In good general health as determined by the Investigator's review of medical history, concomitant medications, physical examination, clinical laboratory tests, and ECG evaluations
- Male subjects must agree to use barrier contraception (male condom) and not donate sperm during the treatment period and for at least 3 months after the last dose of NM8074. Barrier contraception is required even with documented medical assessment of the surgical success of a vasectomy
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- Female subjects who are of childbearing potential must use highly effective contraception1 or acceptable contraception as defined below, starting at screening and continuing until at least 3 months after the last dose of NM8074. Female subjects must not donate ova during the screening and treatment periods and for at least 3 months after the last dose of NM8074
- Highly effective contraceptive methods for female subjects are as follows:
- Combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation: i. Oral contraceptives (e.g., oral, injected, implanted) or intrauterine ii. Intravaginal iii. Transdermal b. Progesterone-only hormonal contraception associated with inhibition of ovulation: i. Oral ii. Injectable iii. Implantable c. Intrauterine Device d. Intrauterine hormone-releasing system e. Bilateral tubal occlusion/tubal ligation (or comparable procedure)
- Women of Non-childbearing Potential
- Postmenopausal: i. 12 continuous months of natural (spontaneous) amenorrhea without an alternative medical cause and a serum follicle-stimulating hormone (FSH) level
- 40 mIU/mL ii. 6 weeks after surgical bilateral oophorectomy with or without hysterectomy b. Post-hysterectomy
- Sexual Abstinence Subjects who practice true abstinence, because of the subject's lifestyle choice (i.e., the subject should not become abstinent just for the purpose of study participation), are exempt from contraceptive requirements. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception. For subjects who practice true abstinence, subjects must be abstinent for at least 6 months prior to screening and must agree to remain abstinent from the time of signing the Informed Consent Form until the end of study.
- Same-sex Relationships For subjects who are exclusively in same-sex relationships, contraceptive requirements do not apply. A subject in a same-sex relationship at the time of signing the Informed Consent Form (ICF) must agree to refrain from engaging in a heterosexual relationship from the time of signing the ICF until the end of study
- Has received the MenB Bexsero® vaccination against Neisseria meningitidis serogroup B (consisting of 2 intramuscular injections, 30 days apart) with the first injection at least 45 days prior to study drug initiation, and the second injection no later than 15 days prior to study drug initiation, and/or provides documentation of positive titer response precluding revaccination
- Has received the MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccine solution against Neisseria meningitidis serogroups A, C, Y, and W-135 (consisting of 1 intramuscular injection) at least 45 days prior to study drug initiation with confirmation of response acceptable by PI, and/or provides documentation of positive titer response precluding re-vaccination
- Negative serum pregnancy test at Screening and Check-In for all female subjects
- Only non-smokers will take priority in enrollment for the study. Should there be a shortage of available healthy volunteers, light smokers (~10 cigarettes/day) will be accepted
Who cannot join
- Subjects who plan to travel during the course of the study to endemic areas as per the Centers for Disease Control and Prevention (CDC) definition for meningococcal meningitis
- Has a currently active systemic infection that requires antibiotic, antifungal, antiparasitic, or antiviral medications. Any infection prior to entry into the study must have been cured for 1 month prior to the Screening Visit
- Positive QuantiFERON®-TB test indicating possible tuberculosis (TB) infection, active systemic bacterial, viral, or fungal infection within 14 days prior to dosing
- Has a known history of meningococcal/pneumococcal/gonococcal disease
- Contraindication to receiving meningococcal vaccine, including severe (life-threatening) allergic reaction to a previous dose of meningococcal serogroup B vaccine; severe (life-threatening) allergy to any vaccine component; previous diagnosis of Guillain-Barré Syndrome
- History of unexplained, recurrent infection; or infection requiring treatment with systemic antibiotics within the last 90 days prior to dosing
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- History of latent or active tuberculosis or exposure to endemic areas within 8 weeks prior to the tuberculosis test performed at screening
- Clinically significant abnormalities in urine upon urinalysis to allow investigator discretion and to prevent disqualifications for minor findings of no significance such as mucus in the urine
- Any of the following hematology tests: hemoglobin; total white blood cells (total WBC); absolute neutrophils; and platelets outside the laboratory reference range at Screening and Day -1
- Abnormal urine tests: Clinically significant abnormalities in urine upon urinalysis" to allow investigator discretion and to prevent disqualifications for minor findings of no significance such as mucus in the urine
- History of continuous topical/inhaled or systemic steroid use > 1 month or history of any inhaled or topical immunosuppressive therapy within 90 days prior to study drug administration
- Has any history of or active cardiac disease, including congestive heart failure, angina, any arrhythmia, or clinically significant findings on ECGs
- Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medication or prior emergency room visits or hospitalization
- Has a history of solid organ transplantation; or has kidney, neurologic, metabolic, or other organ system disease that, in the Investigator's opinion, precludes participation in this study
- Has clinically significant liver disease or transaminase (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] levels > 1.5x the upper limit of normal (ULN) measured at Screening and Day-1
- Has total bilirubin levels > 1.5x ULN measured at Screening
- Has an estimated glomerular filtration rate <70 mL/minute/1.73m2 measured at Screening (measured with creatinine clearance or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI))
- Has an abnormal laboratory finding or vital signs outside the specified normal parameters at the Screening Visit which is judged by the PI as clinically significant
- Has any clinically significant ECG abnormality at Screening or Check-In
- History of allergy to excipients of NM8074
- Use of prescription medications within 28 days prior to study drug administration
- Has a body temperature >99.5 °F (37.5 °C) a fever associated with a symptomatic viral or bacterial infection) within 2 weeks prior to the first dosing
- Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV); acquired or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, vasculitis, or seronegative spondyloarthropathies; or any acute or chronic infection, including, but not limited to, hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Is pregnant, lactating, or planning a pregnancy
- Has used any prescribed medication within 14 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives)
- Participation in any experimental small molecule or non-antibody molecule therapy within 60 days prior to dosing on Day 1
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening) of more than 50 mL of blood within 30 days of dosing, or more than 499 mL of blood within 56 days of dosing
- Immunization with a live attenuated vaccine 1 month prior to dosing or planned vaccination during the course of the study (except for the vaccination planned by the study protocol)
- History of use of illegal recreational drugs within 1 year prior to Screening
- Has used any over-the-counter medicinal products, including herbal and dietary supplements, within 7 days prior to the first admission or has plans to use during the study (with the exception of approved daily doses of acetaminophen, ibuprofen, or aspirin for the treatment of minor discomfort)
- Is currently participating in any other type of clinical trial
- Has previously been randomized and withdrawn from this study
- Has active alcohol or substance abuse or history of alcohol or substance abuse within the 6 months prior to randomization or has a positive result on urine drug or breath alcohol screen during the Screening Visit. The use of alcohol is prohibited for 48 hours prior to Check-In and during confinement.
- Subjects with any medical history, conditions, or risks, which, in the opinion of the Investigator, may interfere with the subject's full participation in the study, or compliance with the protocol, poses any additional risk for the subject, or confounds the assessment of the subject or outcome of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of NM8074 Administered Intravenously to Healthy Subjects
This is a Phase 1 randomized, double-blind, placebo-controlled, single administration, sequential cohort with sentinel dosing, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 in healthy subjects. This study will include 5 cohorts, with each cohort consisting of a total of 8 healthy subjects, including both males and females, randomized in a 3:1 ratio of NM8074 to placebo (6 subjects assigned to NM8074 and 2 subjects assigned to placebo).
Read the detailed description
NM8074 is a novel, recombinant, humanized monoclonal antibody. NM8074 selectively binds to human Factor Bb with high affinity and blocks the formation of Alternative Pathway (AP) driven C3 and C5 convertases. Both C3 and C5 convertases are critical for exacerbation and amplification of the AP in complement-mediated disorders. 06-101-FIH-NM8074 is the first-in-human clinical trial for NM8074 which is intended to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 when delivered as a single intravenous infusion to healthy volunteers. Doses will be escalated in each of the 5 sequential cohorts using sentinel dosing.
- Conditions
- Healthy
- Being tested
- NM8074, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NM8074Drug
Novel, recombinant, humanized monoclonal antibody that selectively binds to human Factor Bb with high affinity and blocks the formation of Alternative Pathway (AP) driven C3 and C5 convertases
PlaceboDrug
Saline Placebo
| Study group | Role | What they receive |
|---|---|---|
| NM8074 | Experimental | 6 subjects per each of the 5 cohorts will receive a single dose of NM8074 administered via IV (intravenous) infusion at 0.3, 1.0, 3.0, 10, or 20 mg/kg Receives: Drug: NM8074 |
| Placebo | Placebo comparator | 2 subjects per each of the 5 cohorts will receive saline placebo administered via IV infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse events will be graded according to the CTCAE v4.03. If the AE term is not described in the grading scales, the AE severity shall be reported according to the following:
- Grade I: Mild (awareness of sign or symptom, but easily tolerated)
- Grade II: Moderate (discomfort sufficient to cause interference with normal activities)
- Grade III: Severe (incapacitating, with inability to perform normal activities)
- Grade IV: Life threatening
- Grade V: Fatal
Measured: Up to 71 days post-dose
Secondary outcomes (11)
Maximum observed serum concentration (Cmax)
Measured: Up to 71 days post-dose
Time to maximum observed serum concentration (tmax)
Measured: Up to 71 days post-dose
Area under the serum concentration versus time curve from time zero to the last quantifiable concentration (AUCt)
Measured: Up to 71 days post-dose
AUC from time zero to infinity (AUC∞)
Measured: Up to 71 days post-dose
Terminal elimination rate constant (λz)
Measured: Up to 71 days post-dose
Terminal half-life (t½)
Measured: Up to 71 days post-dose
Total clearance (CL)
Measured: Up to 71 days post-dose
Volume of distribution (Vd)
Measured: Up to 71 days post-dose
Change from Baseline or Percent Change from Baseline in Levels of Complement Component C3b via Alternative Pathway (AP) of Complement Activity
Measured: Up to 71 days post-dose
Change from Baseline or Percent Change from Baseline in Levels of Membrane Attack Complex (MAC) via the Alternative Pathway (AP) of Complement Activity
Measured: Up to 71 days post-dose
Number of Participants with Antidrug Antibodies (ADAs) to NM8074
Measured: Up to 71 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start12 Aug 2020
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Eligible subjects who meet the inclusion/exclusion criteria will be randomized on Day 1 to either NM8074 or placebo. The sentinel pair in each of the 5 dose cohorts will be randomized in a 1:1 ratio to receive NM8074 or placebo. The remaining subjects will be randomized in a 5:1 ratio to NM8074 to placebo. Dose escalation will occur in sequential cohorts once safety has been evaluated in the prior cohort.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovelMed Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642546
- Sponsor's protocol ID
- 06-101-FIH-NM8074
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 8 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of NM8074 Administered Intravenously to Healthy Subjects
- ClinicalTrials.gov ID
- NCT05642546
- Acronym / sponsor ID
- 06-101-FIH-NM8074
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NovelMed TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Labcorp Corporation of America Holdings, Inc
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 randomized, double-blind, placebo-controlled, single administration, sequential cohort with sentinel dosing, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 in healthy subjects. This study will include 5 cohorts, with each cohort consisting of a total of 8 healthy subjects, including both males and females, randomized in a 3:1 ratio of NM8074 to placebo (6 subjects assigned to NM8074 and 2 subjects assigned to placebo).
Detailed description
NM8074 is a novel, recombinant, humanized monoclonal antibody. NM8074 selectively binds to human Factor Bb with high affinity and blocks the formation of Alternative Pathway (AP) driven C3 and C5 convertases. Both C3 and C5 convertases are critical for exacerbation and amplification of the AP in complement-mediated disorders. 06-101-FIH-NM8074 is the first-in-human clinical trial for NM8074 which is intended to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 when delivered as a single intravenous infusion to healthy volunteers. Doses will be escalated in each of the 5 sequential cohorts using sentinel dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Eligible subjects who meet the inclusion/exclusion criteria will be randomized on Day 1 to either NM8074 or placebo. The sentinel pair in each of the 5 dose cohorts will be randomized in a 1:1 ratio to receive NM8074 or placebo. The remaining subjects will be randomized in a 5:1 ratio to NM8074 to placebo. Dose escalation will occur in sequential cohorts once safety has been evaluated in the prior cohort.
| Arm | Type | Receives |
|---|---|---|
| NM8074 | Experimental | Drug: NM80746 subjects per each of the 5 cohorts will receive a single dose of NM8074 administered via IV (intravenous) infusion at 0.3, 1.0, 3.0, 10, or 20 mg/kg |
| Placebo | Placebo comparator | Drug: Placebo2 subjects per each of the 5 cohorts will receive saline placebo administered via IV infusion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Male or Female subjects ≥18 years to ≤60 years of age, inclusive
- Body mass index (BMI) between 18 kg/m2 and 32 kg/m2, inclusive and weigh at least 50 kg
- QT interval (Fridericia's correction [QTcF]); QTcF ≤ 450 msec for males and ≤ 470 msec for females at Screening and prior to dosing on Admittance Day -1
- Willing and able to give signed Informed Consent and comply with the study visit schedule
- In good general health as determined by the Investigator's review of medical history, concomitant medications, physical examination, clinical laboratory tests, and ECG evaluations
Key exclusion criteria (34 listed)
- Subjects who plan to travel during the course of the study to endemic areas as per the Centers for Disease Control and Prevention (CDC) definition for meningococcal meningitis
- Has a currently active systemic infection that requires antibiotic, antifungal, antiparasitic, or antiviral medications. Any infection prior to entry into the study must have been cured for 1 month prior to the Screening Visit
- Positive QuantiFERON®-TB test indicating possible tuberculosis (TB) infection, active systemic bacterial, viral, or fungal infection within 14 days prior to dosing
- Has a known history of meningococcal/pneumococcal/gonococcal disease
- Contraindication to receiving meningococcal vaccine, including severe (life-threatening) allergic reaction to a previous dose of meningococcal serogroup B vaccine; severe (life-threatening) allergy to any vaccine component; previous diagnosis of Guillain-Barré Syndrome
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 |
|---|---|---|
| NM8074Novel, recombinant, humanized monoclonal antibody that selectively binds to human Factor Bb with high affinity and blocks the formation of Alternative Pathway (AP) driven C3 and C5 convertases | Drug | NM8074 |
| PlaceboSaline Placebo | Drug | Placebo |
Primary outcome
Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 71 days post-dose
Adverse events will be graded according to the CTCAE v4.03. If the AE term is not described in the grading scales, the AE severity shall be reported according to the following: * Grade I: Mild (awareness of sign or symptom, but easily tolerated) * Grade II: Moderate (discomfort sufficient to cause interference with normal activities) * Grade III: Severe (incapacitating, with inability to perform normal activities) * Grade IV: Life threatening * Grade V: Fatal
11 secondary outcomes
Maximum observed serum concentration (Cmax)
Time frame: Up to 71 days post-dose
Time to maximum observed serum concentration (tmax)
Time frame: Up to 71 days post-dose
Area under the serum concentration versus time curve from time zero to the last quantifiable concentration (AUCt)
Time frame: Up to 71 days post-dose
AUC from time zero to infinity (AUC∞)
Time frame: Up to 71 days post-dose
Terminal elimination rate constant (λz)
Time frame: Up to 71 days post-dose
Terminal half-life (t½)
Time frame: Up to 71 days post-dose
Total clearance (CL)
Time frame: Up to 71 days post-dose
Volume of distribution (Vd)
Time frame: Up to 71 days post-dose
Change from Baseline or Percent Change from Baseline in Levels of Complement Component C3b via Alternative Pathway (AP) of Complement Activity
Time frame: Up to 71 days post-dose
Change from Baseline or Percent Change from Baseline in Levels of Membrane Attack Complex (MAC) via the Alternative Pathway (AP) of Complement Activity
Time frame: Up to 71 days post-dose
Number of Participants with Antidrug Antibodies (ADAs) to NM8074
Time frame: Up to 71 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 NM8074 in people with Healthy, run by NovelMed Therapeutics 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 18 inclusion and 34 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 8 Dec 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Monitoring of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 71 days post-dose). 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 8 Dec 2022.