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

October 19, 2017 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Local Institution
  • Georgia
      • Tbilisi, Georgia, 0112
        • Local Institution
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of, MD-2025
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of safety and tolerability of BMS-986184 as assessed by vital sign measurements
Time Frame: Up to 183 days
Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by physical examination findings
Time Frame: Up to 183 days
Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by clinical laboratory test results
Time Frame: Up to 183 days
Up to 183 days
Composite of safety and tolerability of BMS-986184 as assessed by Electrocardiogram (ECG) assessments
Time Frame: Up to 183 days
Up to 183 days
Composite of incidence, severity and outcome of all Adverse Events (AEs)
Time Frame: Up to 183 days
Up to 183 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2016

Primary Completion (Actual)

September 27, 2017

Study Completion (Actual)

September 27, 2017

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 9, 2016

First Posted (Estimate)

August 11, 2016

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 19, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM012-004
  • 2016-000895-72 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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