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

Phase 1

Terminated

• Conditions: Healthy Volunteers; Ulcerative Colitis
• Interventions: Drug: BMS-986184; Drug: Placebo matching BMS-986184

• Registration Number: NCT02864264
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-11
• Study Start: 2016-09-14
• Primary Completion: 2017-09-27
• Study Completion: 2017-09-27
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-19
• Last Update Posted: 2017-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose (SAD) - IV Panel	BMS-986184	Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184
Single Ascending Dose (SAD) - IV Panel	Placebo matching BMS-986184	Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184
Single Ascending Dose (SAD) - SC Panel	BMS-986184	Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184
Single Ascending Dose (SAD) - SC Panel	Placebo matching BMS-986184	Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184
Multiple Ascending Dose (MAD) - IV Panel	BMS-986184	Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Multiple Ascending Dose (MAD) - IV Panel	Placebo matching BMS-986184	Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Proof of Mechanism (POM) - IV Panel	BMS-986184	Multiple IV doses of BMS-986184 or placebo matching BMS-986184
Proof of Mechanism (POM) - IV Panel	Placebo matching BMS-986184	Multiple IV doses of BMS-986184 or placebo matching BMS-986184

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇲🇩 Chisinau, Moldova, Republic of