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

NCT05638282 | Completed Phase 1 FDA Drug

• 1 other identifier: IM042-005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Healthy; Chinese; Cendakimab

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (2)

Cendakimab

EXPERIMENTAL

Drug: Cendakimab

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Cendakimab DRUG

Specified dose on specified days

Also known as: CC-93538, BMS-986355, RPC4046

Cendakimab

Placebo DRUG

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Guangzhou, Guangdong, 510080, China

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

cendakimab

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 6, 2022
• Study Start: February 15, 2023
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)