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

Tauopathies Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294851
• Other study ID #: CN002-001
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2014
• Last updated: October 31, 2017
• Start date: December 31, 2014
• Est. completion date: April 30, 2016

Study information

• Verified date: October 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 30, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tauopathies

Intervention

Drug:
• BMS-986168

• BMS-986168 Placebo

Locations

Country	Name	City	State
United States	WCCT Global, LLC	Cypress	California
United States	Covance Clinical Research Unit Inc.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 months