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The purpose of this study is to evaluate the drug levels of cendakimab delivered subcutaneously in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cendakimab | Drug | Specified Dose on Specified Days |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 clinical laboratory abnormalities |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials Llc | Anaheim | California | 92801 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40374841 | Derived | Zhang P, De Oliveira CHMC, Yu K, Basdeo S, Charriez CM, Syto M, Thomas M, Murthy B. Pharmacokinetic Characterization of Cendakimab Administered with Different Devices and at Different Injection Sites in Healthy Participants. Eur J Drug Metab Pharmacokinet. 2025 Jul;50(4):307-317. doi: 10.1007/s13318-025-00949-0. Epub 2025 May 15. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| ID | Term |
|---|---|
| C000625155 | cendakimab |
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| 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 |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |