Overview
A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2022-12-27
2022-12-27
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
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