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

July 31, 2023 updated by: Bristol-Myers Squibb

A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Subcutaneous Doses of Cendakimab in Chinese Healthy Participants

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • 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
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Local Institution - 0001

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

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Other protocol-defined inclusion/exclusion criteria apply.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: Cendakimab
Drug: Cendakimab
Specified dose on specified days
Other Names:
  • CC-93538, BMS-986355, RPC4046

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Serum Concentration (Cmax)
Time Frame: Predose and at multiple timepoints (up to 105 days) after dosing
Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T))
Time Frame: Predose and at multiple timepoints (up to 105 days) after dosing
Predose and at multiple timepoints (up to 105 days) after dosing
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF))
Time Frame: Predose and at multiple timepoints (up to 105 days) after dosing
Predose and at multiple timepoints (up to 105 days) after dosing

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Treatment-emergent Adverse Events
Time Frame: Day 1 through Day 105
Day 1 through Day 105
Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests
Time Frame: Screening (Days -28 to -1) through Day 105
Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Vital Signs
Time Frame: Screening (Days -28 to -1) through Day 105
Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Physical Examinations
Time Frame: Screening (Days -28 to -1) through Day 105
Screening (Days -28 to -1) through Day 105
Number of Participants with Clinically Significant Changes in Electrocardiograms
Time Frame: Screening (Days -28 to -1) through Day 105
Screening (Days -28 to -1) through Day 105

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

February 15, 2023

Primary Completion (Actual)

June 27, 2023

Study Completion (Actual)

June 27, 2023

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 6, 2022

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IM042-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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