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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Cendakimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05337345

IM042-003

Details and patient eligibility

About

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

Enrollment: 104 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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104 participants in 2 patient groups

Part 1

Experimental group

Treatment:

Drug: Cendakimab

Part 2

Experimental group

Treatment:

Drug: Cendakimab