A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants

NCT05337345 | Completed Phase 1 FDA Drug

• 1 other identifier: IM042-003
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Cendakimab

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax)

  Up to Day 105

• Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T))

  Up to Day 105

• AUC from time zero extrapolated to infinite time (AUC(INF))

  Up to Day 105

Secondary Outcomes (11)

• Number of participants with treatment emergent adverse events (TEAEs)

  Up to Day 107

• Number of Participants with Adverse Events (AEs)

  Up to Day 107

• Number of participants with clinical laboratory abnormalities

  Up to Day 107

• Number of participants with vital sign abnormalities

  Up to Day 107

• Number of participants with physical examination abnormalities

  Up to Day 107

Study Arms (2)

Part 1

EXPERIMENTAL

Drug: Cendakimab

Part 2

EXPERIMENTAL

Drug: Cendakimab

Interventions

Cendakimab DRUG

Specified Dose on Specified Days

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

Part 1; Part 2

Eligibility Criteria

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

You may qualify if:

• Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECGs, and clinical laboratory determinations
• Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2
• Body weight ≥40.0 kg

You may not qualify if:

• History of clinically significant infection within 4 weeks of dosing on Day 1
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
• History of clinically significant allergic reaction to any drug, biologic, food or vaccine

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Anaheim Clinical Trials Llc

Anaheim, California, 92801, United States

Location

Related Publications (1)

• Zhang P, De Oliveira CHMC, Yu K, Basdeo S, Charriez CM, Syto M, Thomas M, Murthy B. Pharmacokinetic Characterization of Cendakimab Administered with Different Devices and at Different Injection Sites in Healthy Participants. Eur J Drug Metab Pharmacokinet. 2025 Jul;50(4):307-317. doi: 10.1007/s13318-025-00949-0. Epub 2025 May 15.

  PMID: 40374841 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: May 2, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

US (1)