A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects

October 31, 2017 updated by: Biogen
This is a randomized, double-blind, placebo controlled, single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.

Study Type

Interventional

Enrollment (Actual)

65

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

  • United States
    • California
      • Cypress, California, United States, 90630
        • WCCT Global, LLC
    • Texas
      • Dallas, Texas, United States, 75247
        • Covance Clinical Research Unit Inc.

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male and female subjects, who have no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations.
  • Body Mass Index (BMI) of 18.5-30 kg/m^2, inclusive. BMI=weight (kg)/[height(m)]^2.
  • Males and Females, not of child-bearing potential, ages 21 to 65 years, inclusive. Female subjects must have documented proof that they are not of childbearing potential.
  • Male subjects must be willing to use effective birth control and refrain from sperm donation during the entire study and for 200 days after dosing has been completed.

Exclusion Criteria:

  • Women who are of childbearing potential or breastfeeding.
  • Any significant acute or chronic medical illness.
  • Any history of cancer within 5 years of enrollment.
  • Any major surgery within 4 weeks of study drug administration.
  • Donation of blood or serum > 500 mL to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration.
  • Participation in a clinical study (except a screening visit) within 4 weeks (or 5 half lives, whichever is longer), of study drug administration.
  • Inability to be venipunctured and/or tolerate venous access.
  • Has smoked or used tobacco products within 6 months prior to study drug administration.
  • Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Ascending dose cohorts
Single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.
Drug: BMS-986168
Other Names:
  • Other Names: BIIB092
Placebo Comparator: Placebo
BMS-986168 Placebo
Drug: BMS-986168 Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability, as measured by incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, and physical and neurological examinations.
Time Frame: 8 months
To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects.
8 months

Collaborators and Investigators

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

Sponsor

Biogen

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)

December 31, 2014

Primary Completion (Actual)

April 30, 2016

Study Completion (Actual)

April 30, 2016

Study Registration Dates

First Submitted

November 12, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 19, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN002-001

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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