Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

NCT02228707 | Completed Phase 1

• 1 other identifier: 231HV102
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of the study are to evaluate the safety and tolerability of multiple doses of BIIB061 administered to healthy adults. The secondary objective is to determine the multiple-dose PK profile of BIIB061 in this study population.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of participants experiencing AEs

  Up to 28 days post treatment period (Day 1 to Day 56)

Secondary Outcomes (1)

• Plasma BIIB061 Concentration

  Up to 28 days post treatment period (Day 1 to Day 56)

Study Arms (2)

BIIB061

EXPERIMENTAL

Participants receive BIIB061

Drug: BIIB061

Placebo

PLACEBO COMPARATOR

Participants receive matched placebo

Other: Placebo

Interventions

BIIB061 DRUG

Participants receive BIIB061

BIIB061

Placebo OTHER

Matched placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone \[FSH\] levels determined at screening to be in the postmenopausal range) or surgically sterile females
• Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
• Must agree to abstain from alcohol ingestion for the duration of the study.
• Must agree to abstain from consumption of grapefruit or grapefruit-containing products for the duration of the study, starting at least 24 hours prior to admission to the inpatient facility.
• Must agree to abstain from taking St. John's Wort (herbal preparation) for the duration of the study
• Must agree to abstain from any vigorous exercise (as determined by the Investigator) for the duration of the study.
• Must have a body mass index of 18 to 30 kg/m2, inclusive.

You may not qualify if:

• History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
• Presence of a metal device (e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) that are contraindications for MRI.
• History of asthma, wheezing, allergies involving the lungs, or airway obstruction.
• History of bronchodilator or inhaler use.
• Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
• Inability or unwillingness to comply with study requirements.
• Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: August 29, 2014
• Study Start: August 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

US (1)