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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Cendakimab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05638282

IM042-005

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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25 participants in 2 patient groups, including a placebo group

Cendakimab

Experimental group

Treatment:

Drug: Cendakimab

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo