Healthy Volunteers
Conditions
Keywords
Pharmacokinetics, Cendakimab
Brief summary
The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.
Interventions
DRUGCendakimab
Specified Dose on Specified Days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 treatment emergent adverse events (TEAEs) | 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 |
| Number of participants with concomitant procedures | Up to Day 107 |
| Number of Participants with Adverse Events (AEs) | Up to Day 107 |
| Number of participants with clinical laboratory abnormalities | Up to Day 107 |
Countries
United States
Outcome results
None listed