A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of Intravenously Administered BMS-986168 in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Tauopathies
In brief
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.
Key facts
- Study ID
- NCT02294851
- Run by
- Biogen
- People needed
- 65
- Starts
- 2014-12-31
- Expected to finish
- 2016-04-30
- Last updated by the study team
- 2017-11-06
Who can join
Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- WCCT Global, LLC — Cypress, California, United States
- Covance Clinical Research Unit Inc. — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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