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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000895-72 | EudraCT Number |
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Adverse change in the risk/benefit
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The primary purpose of this study is to determine if single and multiple doses of BMS-986184 are safe and well tolerated in healthy male and female subjects. The primary purpose of the proof of mechanism study is to determine safety and efficacy in patients with ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Ascending Dose (SAD) - IV Panel | Experimental | Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184 |
|
| Single Ascending Dose (SAD) - SC Panel | Experimental | Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184 |
|
| Multiple Ascending Dose (MAD) - IV Panel | Experimental | Multiple IV doses of BMS-986184 or placebo matching BMS-986184 |
|
| Proof of Mechanism (POM) - IV Panel | Experimental | Multiple IV doses of BMS-986184 or placebo matching BMS-986184 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986184 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements | Up to 183 days | |
| Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings | Up to 183 days | |
| Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results | Up to 183 days | |
| Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments | Up to 183 days | |
| Composite of incidence, severity and outcome of all Adverse Events (AEs) | Up to 183 days |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could 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 | Melbourne | Victoria | 3004 | Australia | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Placebo matching BMS-986184 | Drug |
|
| Tbilisi |
| 0112 |
| Georgia |
| Local Institution | Chisinau | MD-2025 | Moldova |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000906 | Antibodies |
| ID | Term |
|---|---|
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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