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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05638282
• Other study ID #: IM042-005
• Status: Completed
• Phase: Phase 1
• Start date: February 15, 2023
• Est. completion date: June 27, 2023

Study information

• Verified date: July 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Cendakimab
Specified dose on specified days
• Placebo
Specified dose on specified days

Locations

Country	Name	City	State
China	Local Institution - 0001	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax)		Predose and at multiple timepoints (up to 105 days) after dosing
Primary	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
Primary	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	Number of Participants with Treatment-emergent Adverse Events		Day 1 through Day 105
Secondary	Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests		Screening (Days -28 to -1) through Day 105
Secondary	Number of Participants with Clinically Significant Changes in Vital Signs		Screening (Days -28 to -1) through Day 105
Secondary	Number of Participants with Clinically Significant Changes in Physical Examinations		Screening (Days -28 to -1) through Day 105
Secondary	Number of Participants with Clinically Significant Changes in Electrocardiograms		Screening (Days -28 to -1) through Day 105

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting