CompletedNCT04569695Updated Mar 30, 2025

A Study of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Participants

A Phase 1 interventional study of JNJ-70033093 in Healthy, sponsored by Janssen Research & Development, LLC. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-30.

Sponsored by Janssen Research & Development, LLC · Phase 1, Interventional, and Other

From the registry’s dates

Primary completion was Dec 2021, 4 years 10 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Healthy

In context

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

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

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 40 participants (actual)

Study arms

Experimental
Part 1: Cohort A: JNJ-70033093
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.
Drug: JNJ-70033093
Experimental
Part 1: Cohort B: JNJ-70033093
Participants will receive Dose 1 of JNJ-70033093 twice daily (BID) from Days 1 to 8.
Drug: JNJ-70033093
Experimental
Part 1: Cohort C: JNJ-70033093
Participants will receive Dose 2 of JNJ-70033093 BID from Days 1 to 8.
Drug: JNJ-70033093
Experimental
Part 2: Cohort D: JNJ-70033093
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.
Drug: JNJ-70033093

Interventions

DrugJNJ-70033093
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
Also known as: BMS-986177

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)

Secondary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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
Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay.
Time frame: Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)

Study locations

1 site

West China Hospital Si Chuan University
Chengdu, 610041, China

References and documents

Individual participant data

Plan to share: 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

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04569695
Lead sponsor: Janssen Research & Development, LLC
Responsible party: Sponsor
First posted: Sep 30, 2020
Start date: Mar 8, 2021
Primary completion: Dec 4, 2021
Completion: Dec 16, 2021
Last update: Mar 30, 2025

Study contacts

Janssen Research & Development, LLC Clinical Trial

study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Janssen Research & Development, LLC

Start the discussion