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

NCT ID: NCT02864264

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-14

Study Completion Date

2017-09-27

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.

Detailed Description

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Conditions

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Healthy Volunteers Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single Ascending Dose (SAD) - IV Panel

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

Group Type EXPERIMENTAL

BMS-986184

Intervention Type DRUG

Placebo matching BMS-986184

Intervention Type DRUG

Single Ascending Dose (SAD) - SC Panel

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

Group Type EXPERIMENTAL

BMS-986184

Intervention Type DRUG

Placebo matching BMS-986184

Intervention Type DRUG

Multiple Ascending Dose (MAD) - IV Panel

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

Group Type EXPERIMENTAL

BMS-986184

Intervention Type DRUG

Placebo matching BMS-986184

Intervention Type DRUG

Proof of Mechanism (POM) - IV Panel

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

Group Type EXPERIMENTAL

BMS-986184

Intervention Type DRUG

Placebo matching BMS-986184

Intervention Type DRUG

Interventions

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BMS-986184

Intervention Type DRUG

Placebo matching BMS-986184

Intervention Type DRUG

Other Intervention Names

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anti - interferon gamma-induced protein 10(IP-10) antibody

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Melbourne, Victoria, Australia

Site Status

Local Institution

Tbilisi, , Georgia

Site Status

Local Institution

Chisinau, , Moldova

Site Status

Countries

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Romania Australia Georgia Moldova

Related Links

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http://bms.com/studyconnect/Pages/home.aspx

BMS Clinical Trial Patient Recruiting

http://www.bms.com/clinical_trials/Pages/Investigator_inquiry_form.aspx

Investigator Inquiry Form

Other Identifiers

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2016-000895-72

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IM012-004

Identifier Type: -

Identifier Source: org_study_id