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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Placebo; Drug: Cendakimab

• Registration Number: NCT05638282
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-06
• Study Start: 2023-02-15
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-31
• Last Update Posted: 2023-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Cendakimab	Cendakimab	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Serum Concentration (Cmax)	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))	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))	Predose and at multiple timepoints (up to 105 days) after dosing

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution - 0001; 🇨🇳 Guangzhou, Guangdong, China