Clincosm LogoSign in Get a demo

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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05638282
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
4.1
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Apr 20, 2023
Anticipated Study Completion Date :
Apr 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cendakimab

Drug: Cendakimab
Specified dose on specified days
Other Names:
  • CC-93538, BMS-986355, RPC4046

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Observed Serum Concentration (Cmax) [Predose and at multiple timepoints (up to 105 days) after dosing]

    2. Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) [Predose and at multiple timepoints (up to 105 days) after dosing]

    3. Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF)) [Predose and at multiple timepoints (up to 105 days) after dosing]

    Secondary Outcome Measures

    1. Number of Participants with Treatment-emergent Adverse Events [Day 1 through Day 105]

    2. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests [Screening (Days -28 to -1) through Day 105]

    3. Number of Participants with Clinically Significant Changes in Vital Signs [Screening (Days -28 to -1) through Day 105]

    4. Number of Participants with Clinically Significant Changes in Physical Examinations [Screening (Days -28 to -1) through Day 105]

    5. Number of Participants with Clinically Significant Changes in Electrocardiograms [Screening (Days -28 to -1) through Day 105]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution - 0001 Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05638282
    Other Study ID Numbers:
    • IM042-005
    First Posted:
    Dec 6, 2022
    Last Update Posted:
    Dec 6, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Bristol-Myers Squibb
    Healthy
    Chinese
    Cendakimab

    Study Results

    No Results Posted as of Dec 6, 2022