A Study to Evaluate the Drug Levels of Cendakimab Delivered Subcutaneously in Healthy Participants
- Registration Number
- NCT05337345
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 104
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1 Cendakimab - Part 2 Cendakimab -
- Primary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) Up to Day 105 Area under the concentration-time curve (AUC) from time zero to time of last quantifiable concentration (AUC(0-T)) Up to Day 105 AUC from time zero extrapolated to infinite time (AUC(INF)) Up to Day 105
- Secondary Outcome Measures
Name Time Method Number of participants with clinical laboratory abnormalities Up to Day 107 Number of participants with treatment emergent adverse events (TEAEs) Up to Day 107 Number of Participants with Adverse Events (AEs) Up to Day 107 Number of participants with vital sign abnormalities Up to Day 107 Number of participants with physical examination abnormalities Up to Day 107 Number of participants with electrocardiogram (ECG) abnormalities Up to Day 107 Number of participants with concomitant medications Up to Day 107 Number of participants with concomitant procedures Up to Day 107 Time of maximum observed concentration (Tmax) Up to Day 105 Terminal half-life (T-HALF) Up to Day 105 Apparent total body clearance (CL/F) Up to Day 105
Trial Locations
- Locations (1)
Anaheim Clinical Trials Llc
🇺🇸Anaheim, California, United States