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

Study Overview
=================
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.

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

Conditions
-----------------
Healthy Participants

Intervention / Treatment
-----------------
* Drug: Cendakimab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cendakimab<br> | Drug: Cendakimab<br>* Specified dose on specified days<br>* Other names: CC-93538, BMS-986355, RPC4046;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Treatment-emergent Adverse Events |  | Day 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 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 Electrocardiograms |  | Screening (Days -28 to -1) through Day 105 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chinese, Cendakimab, Healthy