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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002763-64 | EudraCT Number | ||
| U1111-1252-7566 | Registry Identifier | WHO |
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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 study will guide the selection of the dose range, dosing frequency, and the route of administration for future studies of BMS-986326 in participants with immune-mediated diseases.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment (BMS 986326) IV | Experimental | Intravenous (IV) |
|
| Active Treatment (BMS 986326) SC | Experimental | Subcutaneous (SC) |
|
| Placebo IV | Placebo Comparator |
| |
| Placebo SC | Placebo Comparator |
| |
| Multiple Ascending Dose Placebo SC | Placebo Comparator | Placebo |
|
| Multiple Ascending Dose SC | Experimental | BMS 986326 SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986326 | Biological | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 175 days | |
| Number of participants with clinical laboratory abnormalities | Up to 175 days | |
| Number of participants with vital sign abnormalities | Up to 175 days | |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 175 days | |
| Number of participants with physical examinations abnormalities | Up to 175 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) | Up to 175 days | |
| Time of maximum observed serum concentration (Tmax) | Up to 175 days | |
| Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] |
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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 | Berlin | 10117 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Placebo matching BMS-986326 | Other | Specified dose on specified days |
|
| Multiple Ascending Dose SC | Biological | Specified dose on specified days |
|
| Multiple Ascending Dose Placebo | Other | Specified dose on specified days |
|
| Up to 175 days |
| Geometric mean ratios of test (SC) vs reference (IV): Area under the serum concentration-time curve extrapolated to infinite time [AUC(INF)] | Up to 175 days |
| Change in regulatory T cells (Treg) count | Up to 175 days |
| Change in Treg-to-conventional CD4 cells [Treg-to-Tconv] ratio | Up to 175 days |
| Number of participants with anti-drug antibodies | Up to 175 days |