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

NCT02294851 | Completed Phase 1

• 1 other identifier: CN002-001
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Tauopathies

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Single Ascending dose cohorts

EXPERIMENTAL

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

Drug: BMS-986168

Placebo

PLACEBO COMPARATOR

BMS-986168 Placebo

Drug: BMS-986168 Placebo

Interventions

BMS-986168 DRUG

Also known as: Other Names: BIIB092

Single Ascending dose cohorts

BMS-986168 Placebo DRUG

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

WCCT Global, LLC

Cypress, California, 90630, United States

Location

Covance Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Tauopathies

Interventions

gosuranemab

Condition Hierarchy (Ancestors)

Neurodegenerative Diseases; Nervous System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2014
• First Posted: November 19, 2014
• Study Start: December 31, 2014
• Primary Completion: April 30, 2016
• Study Completion: April 30, 2016
• Last Updated: November 6, 2017

Record last verified: 2017-10

Locations

US (2)