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

March 28, 2025 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Chengdu, China, 610041
        • West China Hospital Si Chuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
Other Names:
  • BMS-986177
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
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
Other Names:
  • BMS-986177
Experimental: Part 1: Cohort C: JNJ-70033093
Participants will receive Dose 2 of JNJ-70033093 BID from Days 1 to 8.
Drug: JNJ-70033093
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
Other Names:
  • BMS-986177
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
JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
Other Names:
  • BMS-986177

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Up to 54 Days
Number of participants who experience at least 1 occurrence of each treatment emergent adverse event (TEAE) will be assessed.
Up to 54 Days
Number of Participants with Clinical Laboratory Abnormalities
Time Frame: Up to 54 Days
Number of participants with clinical laboratories (such as Hematology, Coagulation, Serum chemistry and urinalysis) abnormalities will be assessed.
Up to 54 Days
Number of Participants with Vital Signs Abnormalities
Time Frame: Up to 54 Days
Number of participants with vital sign abnormalities (such as, blood pressure, pulse, respiratory rate, and temperature) will be assessed.
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)
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).
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)
Percentage change from baseline in FXI clotting activity will be measured using a modified aPTT assay.
Up to Day 15 (Cohort A and D) and up to Day 11 (Cohort C and B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 4, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 16, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108806
  • 70033093THR1003 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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