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

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ClinicalTrials.gov Identifier: NCT02294851
Recruitment Status : Completed
First Posted : November 19, 2014
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

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
Tauopathies Drug: BMS-986168 Drug: BMS-986168 Placebo Phase 1

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

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

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 Name: Other Names: BIIB092

Placebo Comparator: Placebo
BMS-986168 Placebo
Drug: BMS-986168 Placebo



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. [ Time Frame: 8 months ]
    To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294851


Locations
United States, California
WCCT Global, LLC
Cypress, California, United States, 90630
United States, Texas
Covance Clinical Research Unit Inc.
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02294851     History of Changes
Other Study ID Numbers: CN002-001
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Tauopathies
Neurodegenerative Diseases
Nervous System Diseases