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

Phase 1

Completed

• Conditions: Tauopathies
• Interventions: Drug: BMS-986168; Drug: BMS-986168 Placebo

• Registration Number: NCT02294851
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-19
• Study Start: 2014-12-31
• Primary Completion: 2016-04-30
• Study Completion: 2016-04-30
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Ascending dose cohorts	BMS-986168	Single ascending dose escalation, safety, tolerability, PK, PD and immunogenicity study of BMS-986168 administered by an intravenous infusion in healthy subjects.
Placebo	BMS-986168 Placebo	BMS-986168 Placebo

Primary Outcome Measures

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

Trial Locations

Locations (2)

WCCT Global, LLC; 🇺🇸 Cypress, California, United States

Covance Clinical Research Unit Inc.; 🇺🇸 Dallas, Texas, United States