Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of BIIB033 in Subjects With Multiple Sclerosis

NCT01244139

Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis

COMPLETED PHASE1

Single-Dose Study of a New Formulation of BIIB061

NCT02521545

Multiple Sclerosis

COMPLETED PHASE1

Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex

NCT01864148

Multiple Sclerosis

COMPLETED PHASE2

A Safety and Efficacy Study of Oral Prolonged-Release Fampridine (BIIB041) in Japanese Participants With Multiple Sclerosis

NCT01917019

Multiple Sclerosis, Remittent Progressive Multiple Sclerosis, Primary Progressive Relapsing-Remitting Multiple Sclerosis +2 more

COMPLETED PHASE3

This is a Randomized Study Comparing Two Doses of INT131 ( 3 mg and 1 mg) Administered Orally (PO) Daily (QD) Versus Placebo 1 Tablet PO QD in Subjects With Treatment-naïve RRMS for ≤ 3 Years

NCT02638038

Multiple Sclerosis, Relapsing Remitting

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Nervous System (CNS) Demyelinating Disease Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1

Group Type EXPERIMENTAL

BIIB033

Intervention Type BIOLOGICAL

single or multiple dose

Placebo

Intervention Type OTHER

single or multiple dose

Cohort 2

A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1

Group Type EXPERIMENTAL

BIIB033

Intervention Type BIOLOGICAL

single or multiple dose

Placebo

Intervention Type OTHER

single or multiple dose

Cohort 3

One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15

Group Type EXPERIMENTAL

BIIB033

Intervention Type BIOLOGICAL

single or multiple dose

Placebo

Intervention Type OTHER

single or multiple dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BIIB033

single or multiple dose

Intervention Type BIOLOGICAL

Placebo

single or multiple dose

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Japanese subjects must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
* Subjects who have lived out of Japan for more than 5 years must not have significantly modified their diets since leaving Japan.
* Must be a nonsmoker or light smoker (\<10 cigarettes per day) and be willing to abstain from using tobacco and tobacco-containing products during the Inpatient Period and for at least 48 hours prior to Day -1, Day 14 (for Cohort 3), and all outpatient visits.
* Must have a body mass index of 18 to 32 kg/m2, inclusive.

Exclusion Criteria

* History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
* Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day -1.
* Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
* History of severe allergic or anaphylactic reactions.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes