Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Healthy Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Participants
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, drug levels, drug effects, and immunogenicity of BMS-986326 after infusion or injection in healthy participants. The results of this ...
Eligibility Criteria
Inclusion
- In good health, as determined by the investigator based on a physical examination at screening
- Body mass index (BMI) ≥ 18 and ≤ 30 kg/m\^2 at screening
- Afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg and supine diastolic BP ≥ 50 and ≤ 90 mmHg and heart rate ≥ 50 and ≤ 90 bpm at screening
- Male participants are eligible to participate in cohorts (A1-B3).Women not of child bearing potential (WNOCBP) are eligible to participate in all cohorts (A1-B3 and C1-C2) Women of child-bearing potential (WOCBP) are only eligible for the subcutaneous (SC) cohorts (B1-B3 and C1-C2)
- Must agree to follow specific methods of contraception, if applicable
Exclusion
- Women who are pregnant or lactating
- History of, or active, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, echocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with healthy participants
- History of serious adverse reaction or hypersensitivity to any (subcutaneous) SC- or (intravenous) IV-administered biological therapeutic, including IV immunoglobulins and human blood products
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
March 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2024
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04736134
Start Date
March 3 2021
End Date
March 14 2024
Last Update
May 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 0001
Berlin, Germany, 10117