Status:
COMPLETED
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects
Lead Sponsor:
Biogen
Conditions:
Tauopathies
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
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...
Detailed Description
This study, previously posted by Bristol-Myers Squibb, has transitioned to Biogen under a licensing agreement.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2016
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT02294851
Start Date
December 31 2014
End Date
April 30 2016
Last Update
November 6 2017
Active Locations (2)
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1
WCCT Global, LLC
Cypress, California, United States, 90630
2
Covance Clinical Research Unit Inc.
Dallas, Texas, United States, 75247