Back to resultsA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects
Primary Purpose
Tauopathies
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMS-986168
BMS-986168 Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tauopathies
Eligibility 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
Sites / Locations
- WCCT Global, LLC
- Covance Clinical Research Unit Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Single Ascending dose cohorts
Placebo
Arm Description
Single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.
BMS-986168 Placebo
Outcomes
Primary Outcome Measures
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.
To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02294851
Brief Title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 31, 2014 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
April 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. 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.
Detailed Description
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tauopathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Ascending dose cohorts
Arm Type
Experimental
Arm Description
Single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
BMS-986168 Placebo
Intervention Type
Drug
Intervention Name(s)
BMS-986168
Other Intervention Name(s)
Other Names: BIIB092
Intervention Type
Drug
Intervention Name(s)
BMS-986168 Placebo
Primary Outcome Measure Information:
Title
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.
Description
To evaluate the safety and tolerability of a single intravenous (IV) infusion of BMS-986168 in healthy subjects.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
WCCT Global, LLC
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Covance Clinical Research Unit Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects
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