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

June 14, 2016 updated by: Biogen

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

Note: Other protocol defined inclusion/ exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BIIB061
Participants receive BIIB061
Drug: BIIB061
Participants receive BIIB061
Placebo Comparator: Placebo
Participants receive matched placebo
Other: Placebo
Matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants experiencing AEs
Time Frame: Up to 28 days post treatment period (Day 1 to Day 56)
Up to 28 days post treatment period (Day 1 to Day 56)

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma BIIB061 Concentration
Time Frame: Up to 28 days post treatment period (Day 1 to Day 56)
Up to 28 days post treatment period (Day 1 to Day 56)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

August 27, 2014

First Submitted That Met QC Criteria

August 27, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Estimate)

June 15, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 231HV102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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