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

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers; Ulcerative Colitis

Treatments: Drug: BMS-986184; Drug: Placebo matching BMS-986184

Study type: Interventional

Funder types: Industry

Identifiers

NCT02864264

IM012-004

2016-000895-72 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 4 patient groups

Single Ascending Dose (SAD) - IV Panel

Experimental group

Description:

Single intravenous (IV) dose of BMS-986184 or placebo matching BMS-986184

Treatment:

Drug: Placebo matching BMS-986184

Drug: BMS-986184

Single Ascending Dose (SAD) - SC Panel

Experimental group

Description:

Single subcutaneous (SC) dose of BMS-986184 or placebo matching BMS-986184

Treatment:

Drug: Placebo matching BMS-986184

Drug: BMS-986184

Multiple Ascending Dose (MAD) - IV Panel

Experimental group

Description:

Multiple IV doses of BMS-986184 or placebo matching BMS-986184

Treatment:

Drug: Placebo matching BMS-986184

Drug: BMS-986184

Proof of Mechanism (POM) - IV Panel

Experimental group

Description:

Multiple IV doses of BMS-986184 or placebo matching BMS-986184

Treatment:

Drug: Placebo matching BMS-986184

Drug: BMS-986184