Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis

Conditions
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Healthy Volunteers, Ulcerative Colitis

Intervention / Treatment
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* Drug: BMS-986184
* Drug: Placebo matching BMS-986184


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Women of childbearing potential must have a negative serum pregnancy test within 24 hours prior to the start of study drug Diagnosis of ulcerative colitis confirmed by endoscopic and histologic evidence (if no previous confirmation of diagnosis is available or if diagnosis is not conclusive, at time of baseline endoscopy, histology must be performed and read locally to confirm diagnosis) Exclusion Criteria: Any bacterial, fungal or viral infection, including tuberculosis, HIV, hepatitis B or hepatitis C Subjects with history of cancer, lymphoproliferative disease, class III or IV congestive heart failure, myocardial infarction, unstable angina pectoris, or any history of significant ocular disease such as glaucoma or retinal disease Other protocol defined inclusion/exclusion criteria could apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Ascending Dose (SAD) - IV Panel<br>Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184 | Drug: BMS-986184<br> <br> * Other names: anti - interferon gamma-induced protein 10(IP-10) antibody;Drug: Placebo matching BMS-986184<br> <br> |
| Experimental: Single Ascending Dose (SAD) - SC Panel<br>Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184 | Drug: BMS-986184<br> <br> * Other names: anti - interferon gamma-induced protein 10(IP-10) antibody;Drug: Placebo matching BMS-986184<br> <br> |
| Experimental: Multiple Ascending Dose (MAD) - IV Panel<br>Multiple IV doses of BMS-986184 or placebo matching BMS-986184 | Drug: BMS-986184<br> <br> * Other names: anti - interferon gamma-induced protein 10(IP-10) antibody;Drug: Placebo matching BMS-986184<br> <br> |
| Experimental: Proof of Mechanism (POM) - IV Panel<br>Multiple IV doses of BMS-986184 or placebo matching BMS-986184 | Drug: BMS-986184<br> <br> * Other names: anti - interferon gamma-induced protein 10(IP-10) antibody;Drug: Placebo matching BMS-986184<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |