HealthyPhase 1NCT04569695
A Study of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Participants
A Phase 1 study testing JNJ-70033093 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in China.
Trial summary
The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese 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?
- JNJ-70033093
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2021to 16 Dec 2021
- 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
- Healthy on the basis of physical examination, medical history, vital signs, Electrocardiogram (ECG), and the results of serum biochemistry, blood coagulation and hematology test and a urinalysis performed at screening. If there are abnormalities, investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator
- Must sign an Informed consent Form (ICF) indicating that they understand the purpose of, and procedures required for the study and is willing to participate in the study
- If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta hCG]) at screening and urine (beta-hCG) pregnancy test on Day -1
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
- Before randomization, a woman must be either not of childbearing potential; of childbearing potential and practicing a highly effective method of contraception and agrees to remain on a highly effective method throughout the study and for at least 34 days after the last dose of study drug; women must have no history of excessive menstrual bleeding or hemorrhage following pregnancy delivery
Who cannot join
- If a woman, pregnant, breast-feeding or planning to become pregnant during the study
- Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection at study screening
- History of, or a reason to believe a subject has a history of, drug or alcohol abuse within the past 1 year, which in the Investigator's opinion would compromise subject's safety and/or compliance with the study procedures
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) and known allergy to the study drug or any of the excipients of the formulation
- Preplanned surgery or procedures that would interfere with the conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, Parallel-group, Single- and Multiple-dose Study to Characterize Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Subjects
The purpose of the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.
- Conditions
- Healthy
- Being tested
- JNJ-70033093
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-70033093Drug
Also called BMS-986177
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort A: JNJ-70033093 | Experimental | Participants will receive Dose 1 of JNJ-70033093 once daily (QD) on Day 1 followed by washout period of 4 days and then Dose 1 of JNJ-70033093 QD from Days 5 to 12. Receives: Drug: JNJ-70033093 |
| Part 1: Cohort B: JNJ-70033093 | Experimental | Participants will receive Dose 1 of JNJ-70033093 twice daily (BID) from Days 1 to 8. Receives: Drug: JNJ-70033093 |
| Part 1: Cohort C: JNJ-70033093 | Experimental | Participants will receive Dose 2 of JNJ-70033093 BID from Days 1 to 8. Receives: Drug: JNJ-70033093 |
| Part 2: Cohort D: JNJ-70033093 | Experimental | Participants will receive Dose 3 of JNJ-70033093 QD on Day 1 followed by washout period of 4 days and then Dose 3 of JNJ-70033093 BID from Days 5 to 12 in Cohort D. Dose escalation to Part 2: Cohort D will occur only after the safety and tolerability data of the Part 1 are assessed. Receives: Drug: JNJ-70033093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort A and D: Plasma Concentration of JNJ-70033093 After Single Dose Administration
Plasma concentration of JNJ-70033093 after single dose administration will be analyzed.
Measured: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Cohort A, B, C and D: Plasma Concentration of JNJ-70033093 After Multiple Dose Administration
Observed plasma concentration of JNJ-70033093 after multiple dose administration will be analyzed.
Measured: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Secondary outcomes (5)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Number of participants who experience at least 1 occurrence of each treatment emergent adverse event (TEAE) will be assessed.
Measured: Up to 54 Days
Number of Participants with Clinical Laboratory Abnormalities
Number of participants with clinical laboratories (such as Hematology, Coagulation, Serum chemistry and urinalysis) abnormalities will be assessed.
Measured: Up to 54 Days
Number of Participants with Vital Signs Abnormalities
Number of participants with vital sign abnormalities (such as, blood pressure, pulse, respiratory rate, and temperature) will be assessed.
Measured: Up to 54 Days
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Activated partial thromboplastin time measures the time to clot formation via the intrinsic (contact) and common pathways, and is dependent on activation of contact factors (such as FXI).
Measured: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Percentage Change From Baseline in FXI Clotting Activity
Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay.
Measured: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start8 Mar 2021
- Primary completion4 Dec 2021
- Study completion16 Dec 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT04569695
- Sponsor's protocol ID
- CR108806
- Other IDs
- 70033093THR1003
- Status last verified
- Mar 2025
- First submitted
- 11 Sep 2020
- Last updated
- 30 Mar 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 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Parallel-group, Single- and Multiple-dose Study to Characterize Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Subjects
- ClinicalTrials.gov ID
- NCT04569695
- Acronym / sponsor ID
- CR108806
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 4 Dec 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 30 Sep 2020 (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 the study is to characterize the pharmacokinetics of single and multiple doses of JNJ-70033093 (BMS-986177) in healthy Chinese participants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort A: JNJ-70033093 | Experimental | Drug: JNJ-70033093Participants will receive Dose 1 of JNJ-70033093 once daily (QD) on Day 1 followed by washout period of 4 days and then Dose 1 of JNJ-70033093 QD from Days 5 to 12. |
| Part 1: Cohort B: JNJ-70033093 | Experimental | Drug: JNJ-70033093Participants will receive Dose 1 of JNJ-70033093 twice daily (BID) from Days 1 to 8. |
| Part 1: Cohort C: JNJ-70033093 | Experimental | Drug: JNJ-70033093Participants will receive Dose 2 of JNJ-70033093 BID from Days 1 to 8. |
| Part 2: Cohort D: JNJ-70033093 | Experimental | Drug: JNJ-70033093Participants will receive Dose 3 of JNJ-70033093 QD on Day 1 followed by washout period of 4 days and then Dose 3 of JNJ-70033093 BID from Days 5 to 12 in Cohort D. Dose escalation to Part 2: Cohort D will occur only after the safety and tolerability data of the Part 1 are assessed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy on the basis of physical examination, medical history, vital signs, Electrocardiogram (ECG), and the results of serum biochemistry, blood coagulation and hematology test and a urinalysis performed at screening. If there are abnormalities, investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the investigator
- Must sign an Informed consent Form (ICF) indicating that they understand the purpose of, and procedures required for the study and is willing to participate in the study
- If a woman, except for postmenopausal women, must have a negative highly sensitive serum (beta human chorionic gonadotropin [beta hCG]) at screening and urine (beta-hCG) pregnancy test on Day -1
- Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies
- Before randomization, a woman must be either not of childbearing potential; of childbearing potential and practicing a highly effective method of contraception and agrees to remain on a highly effective method throughout the study and for at least 34 days after the last dose of study drug; women must have no history of excessive menstrual bleeding or hemorrhage following pregnancy delivery
Key exclusion criteria (5 listed)
- If a woman, pregnant, breast-feeding or planning to become pregnant during the study
- Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]), or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency virus type-1 (HIV-1) or HIV-2 infection at study screening
- History of, or a reason to believe a subject has a history of, drug or alcohol abuse within the past 1 year, which in the Investigator's opinion would compromise subject's safety and/or compliance with the study procedures
- History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) and known allergy to the study drug or any of the excipients of the formulation
- Preplanned surgery or procedures that would interfere with the conduct of the study
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 |
|---|---|---|
| JNJ-70033093Also: BMS-986177JNJ-70033093 capsule will be administered orally as per assigned treatment regimen. | Drug | Part 1: Cohort A: JNJ-70033093, Part 1: Cohort B: JNJ-70033093, Part 1: Cohort C: JNJ-70033093, Part 2: Cohort D: JNJ-70033093 |
Primary outcome
Cohort A and D: Plasma Concentration of JNJ-70033093 After Single Dose Administration
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Plasma concentration of JNJ-70033093 after single dose administration will be analyzed.
Cohort A, B, C and D: Plasma Concentration of JNJ-70033093 After Multiple Dose Administration
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Observed plasma concentration of JNJ-70033093 after multiple dose administration will be analyzed.
5 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 54 Days
Number of Participants with Clinical Laboratory Abnormalities
Time frame: Up to 54 Days
Number of Participants with Vital Signs Abnormalities
Time frame: Up to 54 Days
Change From Baseline in Activated Partial Thromboplastin Time (aPTT)
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
Percentage Change From Baseline in FXI Clotting Activity
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)
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 30 Mar 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 JNJ-70033093 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 30 Mar 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?
Cohort A and D: Plasma Concentration of JNJ-70033093 After Single Dose Administration (time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)). 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 30 Mar 2025.