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The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cendakimab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cendakimab | Drug | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Predose and at multiple timepoints (up to 105 days) after dosing | |
| Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) | Predose and at multiple timepoints (up to 105 days) after dosing | |
| Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time (AUC(INF)) | Predose and at multiple timepoints (up to 105 days) after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events | Day 1 through Day 105 | |
| Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests | Screening (Days -28 to -1) through Day 105 |
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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 |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Guangzhou | Guangdong | 510080 | China |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Term |
|---|---|
| C000625155 | cendakimab |
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| Placebo | Drug | Specified dose on specified days |
|
| Number of Participants with Clinically Significant Changes in Vital Signs | Screening (Days -28 to -1) through Day 105 |
| Number of Participants with Clinically Significant Changes in Physical Examinations | Screening (Days -28 to -1) through Day 105 |
| Number of Participants with Clinically Significant Changes in Electrocardiograms | Screening (Days -28 to -1) through Day 105 |