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

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT02294851
Collaborator
(none)
65
Enrollment
2
Locations
2
Arms
16
Actual Duration (Months)
32.5
Patients Per Site
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
65 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Actual Study Start Date :
Dec 31, 2014
Actual Primary Completion Date :
Apr 30, 2016
Actual Study Completion Date :
Apr 30, 2016

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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. [8 months]

      To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 WCCT Global, LLC Cypress California United States 90630
    2 Covance Clinical Research Unit Inc. Dallas Texas United States 75247

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT02294851
    Other Study ID Numbers:
    • CN002-001
    First Posted:
    Nov 19, 2014
    Last Update Posted:
    Nov 6, 2017
    Last Verified:
    Oct 1, 2017
    Additional relevant MeSH terms:
    Tauopathies

    Study Results

    No Results Posted as of Nov 6, 2017