Status:
COMPLETED
A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2022
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT05337345
Start Date
May 2 2022
End Date
December 15 2022
Last Update
February 10 2023
Active Locations (1)
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1
Anaheim Clinical Trials Llc
Anaheim, California, United States, 92801