HealthyPhase 1NCT04030533
Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants
A Phase 1 study testing Guselkumab (SC): Dose 1, Guselkumab (SC): Dose 2 and Guselkumab (IV): Dose 1 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics (PK) of guselkumab following a single intravenous (IV) or subcutaneous (SC) administration in healthy Chinese participants; to evaluate the PK of ustekinumab following a single IV administration in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Guselkumab (SC): Dose 1, Guselkumab (SC): Dose 2 and Guselkumab (IV): Dose 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2019to 31 Dec 2020
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, urinalysis, measurement of vital signs, and electrocardiogram (ECG)
- A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and Day-1
- Must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 16 weeks after study drug administration
- Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study. However, during the inpatient portion of the study if smoking is not allowed in the inpatient unit, smokers will not be allowed to smoke cannot use nicotine replacement products
- Must agree to abstain from alcohol intake 48 hours before study drug administration and during the inpatient period of the study. After this time, participants must not consume more than 10 grams of alcohol (e.g. 250 milliliter (mL) beer with 5 percent (%) alcohol content) per day for the duration of the study
Who cannot join
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Has had major surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
- Has received an experimental antibody or biologic therapy within the previous 6 months
- Has a history of, or ongoing, chronic, or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Pharmacokinetics of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Subjects
The purpose of this study is to evaluate the pharmacokinetics (PK) of guselkumab following a single intravenous (IV) or subcutaneous (SC) administration in healthy Chinese participants; to evaluate the PK of ustekinumab following a single IV administration in healthy participants.
- Conditions
- Healthy
- Being tested
- Guselkumab (SC): Dose 1, Guselkumab (SC): Dose 2, Guselkumab (IV): Dose 1, Guselkumab (IV): Dose 2, Ustekinumab 6 mg/mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guselkumab (SC): Dose 1Drug
Also called CNTO 1959
Participants will receive a single dose of guselkumab (dose 1) subcutaneously.
Guselkumab (SC): Dose 2Drug
Also called CNTO 1959
Participants will receive a single dose of guselkumab (dose 2) subcutaneously.
Guselkumab (IV): Dose 1Drug
Also called CNTO 1959
Participants will receive a single IV infusion of guselkumab (dose 1).
Guselkumab (IV): Dose 2Drug
Also called CNTO 1959
Participants will receive a single IV infusion of guselkumab (dose 2).
Ustekinumab 6 mg/mLDrug
Also called Stelara
Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Guselkumab (SC): Dose 1 | Experimental | Participants will receive a single subcutaneous (SC) injection of guselkumab (dose 1), administered on Day 1. Receives: Drug: Guselkumab (SC): Dose 1 |
| Cohort 2: Guselkumab (SC): Dose 2 | Experimental | Participants will receive a single SC injection of guselkumab (dose 2), administered on Day 1. Receives: Drug: Guselkumab (SC): Dose 2 |
| Cohort 3: Guselkumab (IV): Dose 1 | Experimental | Participants will receive a single intravenous (IV) infusion of guselkumab (dose 1), administered on Day 1. Receives: Drug: Guselkumab (IV): Dose 1 |
| Cohort 4: Guselkumab (IV): Dose 2 | Experimental | Participants will receive a single IV infusion of guselkumab (dose 2), administered on Day 1. Receives: Drug: Guselkumab (IV): Dose 2 |
| Cohort 5: Ustekinumab (IV): 6 mg/mL | Experimental | Participants will receive a single IV infusion of ustekinumab 6 milligrams per milliliter (mg/mL) solution on Day 1. Receives: Drug: Ustekinumab 6 mg/mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
The Cmax is the maximum observed serum concentration.
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
AUC (0-infinity) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Area Under Serum Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last])
AUC (0-last) area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Elimination Half-Life (T1/2)
Elimination half-life is time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Total Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose is estimated by dividing the total administered dose by the serum area under the serum concentration-time curve from time zero to infinite time (AUC [0-infinity]).
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Volume of Distribution (Vz)
The Vz is total volume of distribution at terminal phase after intravenous (IV) administration, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Time to Reach Maximum Observed Serum Concentration (Tmax)
Tmax is time correspondent to the maximum observed serum concentration.
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Apparent Total Systemic Clearance (CL/F)
Apparent total systemic clearance is clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Apparent Volume of Distribution (Vz/F)
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vz/F) is influenced by the fraction absorbed.
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Absolute Bioavailability (F [%])
Absolute bioavailability is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for ref/D for test)*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of administered drug.
Measured: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Secondary outcomes (2)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Measured: Up to Week 16
Number of Participants with Anti-Guselkumab and Anti-Ustekinumab Antibodies
Participant's serum samples will be collected and screened for antibodies binding to guselkumab and ustekinumab using validated electrochemiluminescence immunoassay analyzer (ECLIA) method for evaluation of potential immunogenicity.
Measured: Predose (Day 1) and on Days 15, 29, 57, and 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start29 Nov 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04030533
- Sponsor's protocol ID
- CR108639
- Other IDs
- CNTO1959CRD1001
- Status last verified
- Jan 2025
- First submitted
- 22 Jul 2019
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Pharmacokinetics of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT04030533
- Acronym / sponsor ID
- CR108639
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 24 Jul 2019 (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.
The purpose of this study is to evaluate the pharmacokinetics (PK) of guselkumab following a single intravenous (IV) or subcutaneous (SC) administration in healthy Chinese participants; to evaluate the PK of ustekinumab following a single IV administration in healthy participants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Guselkumab (SC): Dose 1 | Experimental | Drug: Guselkumab (SC): Dose 1Participants will receive a single subcutaneous (SC) injection of guselkumab (dose 1), administered on Day 1. |
| Cohort 2: Guselkumab (SC): Dose 2 | Experimental | Drug: Guselkumab (SC): Dose 2Participants will receive a single SC injection of guselkumab (dose 2), administered on Day 1. |
| Cohort 3: Guselkumab (IV): Dose 1 | Experimental | Drug: Guselkumab (IV): Dose 1Participants will receive a single intravenous (IV) infusion of guselkumab (dose 1), administered on Day 1. |
| Cohort 4: Guselkumab (IV): Dose 2 | Experimental | Drug: Guselkumab (IV): Dose 2Participants will receive a single IV infusion of guselkumab (dose 2), administered on Day 1. |
| Cohort 5: Ustekinumab (IV): 6 mg/mL | Experimental | Drug: Ustekinumab 6 mg/mLParticipants will receive a single IV infusion of ustekinumab 6 milligrams per milliliter (mg/mL) solution on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be healthy with no clinically significant abnormalities as determined by medical history, physical examination, blood chemistry assessments, hematologic assessments, urinalysis, measurement of vital signs, and electrocardiogram (ECG)
- A woman must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) at screening and Day-1
- Must agree to use an adequate contraception method as deemed appropriate by the investigator; to always use a condom during intercourse and to not donate sperm during the study and for 16 weeks after study drug administration
- Must be a nonsmoker or agree to smoke no more than 10 cigarettes or 2 cigars per day throughout the study. However, during the inpatient portion of the study if smoking is not allowed in the inpatient unit, smokers will not be allowed to smoke cannot use nicotine replacement products
- Must agree to abstain from alcohol intake 48 hours before study drug administration and during the inpatient period of the study. After this time, participants must not consume more than 10 grams of alcohol (e.g. 250 milliliter (mL) beer with 5 percent (%) alcohol content) per day for the duration of the study
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric disease, infection, gastro-intestinal disease, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Has had major surgery, (for example, requiring general anesthesia) within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
- Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
- Has received an experimental antibody or biologic therapy within the previous 6 months
- Has a history of, or ongoing, chronic, or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection
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 |
|---|---|---|
| Guselkumab (SC): Dose 1Also: CNTO 1959Participants will receive a single dose of guselkumab (dose 1) subcutaneously. | Drug | Cohort 1: Guselkumab (SC): Dose 1 |
| Guselkumab (SC): Dose 2Also: CNTO 1959Participants will receive a single dose of guselkumab (dose 2) subcutaneously. | Drug | Cohort 2: Guselkumab (SC): Dose 2 |
| Guselkumab (IV): Dose 1Also: CNTO 1959Participants will receive a single IV infusion of guselkumab (dose 1). | Drug | Cohort 3: Guselkumab (IV): Dose 1 |
| Guselkumab (IV): Dose 2Also: CNTO 1959Participants will receive a single IV infusion of guselkumab (dose 2). | Drug | Cohort 4: Guselkumab (IV): Dose 2 |
| Ustekinumab 6 mg/mLAlso: StelaraParticipants will receive a single IV infusion of ustekinumab 6 mg/mL solution. | Drug | Cohort 5: Ustekinumab (IV): 6 mg/mL |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
The Cmax is the maximum observed serum concentration.
Area Under the Serum Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity])
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
AUC (0-infinity) is the area under the serum concentration versus time curve from time zero to infinity with extrapolation of the terminal phase.
Area Under Serum Concentration From Time Zero to the Last Quantifiable Concentration (AUC [0-last])
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
AUC (0-last) area under the serum concentration versus time curve from time zero to the time corresponding to the last quantifiable concentration.
Elimination Half-Life (T1/2)
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Elimination half-life is time measured for the serum concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Total Systemic Clearance (CL)
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
CL is a quantitative measure of the rate at which a drug substance is removed from the body. The total systemic clearance after intravenous dose is estimated by dividing the total administered dose by the serum area under the serum concentration-time curve from time zero to infinite time (AUC [0-infinity]).
Volume of Distribution (Vz)
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
The Vz is total volume of distribution at terminal phase after intravenous (IV) administration, defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time to Reach Maximum Observed Serum Concentration (Tmax)
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Tmax is time correspondent to the maximum observed serum concentration.
Apparent Total Systemic Clearance (CL/F)
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Apparent total systemic clearance is clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Apparent Volume of Distribution (Vz/F)
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. Apparent volume of distribution after subcutaneous dose (Vz/F) is influenced by the fraction absorbed.
Absolute Bioavailability (F [%])
Time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85
Absolute bioavailability is the percentage of the orally administered dose that is systemically available. It is calculated as (AUC [0-infinity] for test)/(AUC [0-infinity] for reference [ref])*(D for ref/D for test)*100, where the reference treatment is an intravenous administration, AUC (0-infinity) is area under the concentration-time curve from time zero to extrapolated infinite time, and D is the dose of administered drug.
2 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to Week 16
Number of Participants with Anti-Guselkumab and Anti-Ustekinumab Antibodies
Time frame: Predose (Day 1) and on Days 15, 29, 57, and 85
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 3 Feb 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
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 Guselkumab (SC): Dose 1, Guselkumab (SC): Dose 2 and Guselkumab (IV): Dose 1 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
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 5 inclusion and 5 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 3 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 China. 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?
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?
Maximum Observed Serum Concentration (Cmax) (time frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85). The study lists 10 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 3 Feb 2025.