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

• Status: Not yet recruiting
• Trial end date: 2022-12-27
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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