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

NCT ID: NCT02294851

Last Updated: 2017-11-06

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Tauopathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

BMS-986168

Intervention Type DRUG

Placebo

BMS-986168 Placebo

Group Type PLACEBO_COMPARATOR

BMS-986168 Placebo

Intervention Type DRUG

Interventions

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BMS-986168

Intervention Type DRUG

BMS-986168 Placebo

Intervention Type DRUG

Other Intervention Names

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Other Names: BIIB092

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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WCCT Global, LLC

Cypress, California, United States

Site Status

Covance Clinical Research Unit Inc.

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CN002-001

Identifier Type: -

Identifier Source: org_study_id