Skip to main content
OpenTrials
Completed

NCT Number: NCT05638282

A Study to Evaluate the Safety and Tolerability 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cendakimab

Drug

Specified dose on specified days

Other names: CC-93538, BMS-986355, RPC4046

Placebo

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: 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))

    Time frame: 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))

    Time frame: Predose and at multiple timepoints (up to 105 days) after dosing

Secondary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events

    Time frame: Day 1 through Day 105

  2. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Time frame: Screening (Days -28 to -1) through Day 105

  3. Number of Participants with Clinically Significant Changes in Vital Signs

    Time frame: Screening (Days -28 to -1) through Day 105

  4. Number of Participants with Clinically Significant Changes in Physical Examinations

    Time frame: Screening (Days -28 to -1) through Day 105

  5. Number of Participants with Clinically Significant Changes in Electrocardiograms

    Time frame: Screening (Days -28 to -1) through Day 105

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2022
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.