A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy Participants

NCT ID: NCT05638282

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-06-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cendakimab

Group Type EXPERIMENTAL

Cendakimab

Intervention Type DRUG

Specified dose on specified days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Specified dose on specified days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cendakimab

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CC-93538, BMS-986355, RPC4046

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants must be Chinese (both biological parents are ethnically Chinese).
* Body mass index (BMI) of 18.0 through 28.0 kilograms/meter squared (kg/m\^2), inclusive. BMI = weight (kg)/\[height (m)\]\^2.
* Body weight ≥ 50.0 kg.

Exclusion Criteria

* History of clinically significant infection within 4 weeks of dosing on Day 1.
* Significant medical history/condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
* Condition(s) which may confound the ability to interpret data from the study, as determined by the investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Local Institution - 0001

Guangzhou, Guangdong, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IM042-005

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.