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

A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Central Nervous System (CNS) Demyelinating Disease
• Intervention / Treatment: Biological: BIIB033; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS2 9LH
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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.

Key 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1	Biological: BIIB033; single or multiple dose; Other: Placebo; single or multiple dose
Experimental: Cohort 2; A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1	Biological: BIIB033; single or multiple dose; Other: Placebo; single or multiple dose
Experimental: Cohort 3; One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15	Biological: BIIB033; single or multiple dose; Other: Placebo; single or multiple dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to day 113
Number of participants with clinically significant laboratory parameters	Up to day 113
Number of participants with clinically significant vital sign abnormalities	Up to day 113
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities	Up to day 113
Number of participants with clinically significant physical examination abnormalities	Up to day 113
Number of participants with clinically significant neurological examination abnormalities	Up to day 113

Secondary Outcome Measures

Outcome Measure	Time Frame
PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)	Up to day 113
PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)	Up to day 113
PK parameter of BIIB033: AUC over a given dosing interval	Up to day 113
PK parameter of BIIB033: Maximum observed concentration (Cmax)	Up to day 113
PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)	Up to day 113
PK parameter of BIIB033: Terminal elimination half-life (t1/2)	Up to day 113
PK parameter of BIIB033: Volume of distribution at steady state (Vss)	Up to day 113
PK parameter of BIIB033: Clearance (CL)	Up to day 113
PK parameter of BIIB033: accumulation ratio (RAC)	Up to day 113
Number of participants with positive serum BIIB033 antibodies	Up to day 113

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: December 23, 2015
• First Submitted That Met QC Criteria: December 23, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Japanese; Single Ascending Dose (SAD); Multiple Ascending Dose (MAD)
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Multiple Sclerosis; Demyelinating Diseases
• Other Study ID Numbers: 215HV102; 2015-004560-11 (EudraCT Number)