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

A Phase I, Open-Label, Randomized, Two-part Parallel Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Cendakimab Administered Using Autoinjector Versus Using Prefilled Syringe, and to Evaluate the Pharmacokinetics of Cendakimab When Administered by Autoinjector at Different Injection Sites, in Healthy Participants

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Cendakimab

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials Llc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part 1	Drug: Cendakimab; Specified Dose on Specified Days; Other Names: BMS-986355; CC-93538; RPC4046
EXPERIMENTAL: Part 2	Drug: Cendakimab; Specified Dose on Specified Days; Other Names: BMS-986355; CC-93538; RPC4046

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 107
Number of participants with concomitant medications	Up to Day 107
Number of participants with concomitant procedures	Up to Day 107
Time of maximum observed concentration (Tmax)	Up to Day 105
Terminal half-life (T-HALF)	Up to Day 105
Apparent total body clearance (CL/F)	Up to Day 105

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 2, 2022
• Primary Completion (ACTUAL): December 15, 2022
• Study Completion (ACTUAL): December 15, 2022

Study Registration Dates

• First Submitted: April 13, 2022
• First Submitted That Met QC Criteria: April 13, 2022
• First Posted (ACTUAL): April 20, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Cendakimab
• Other Study ID Numbers: IM042-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No