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

Phase 1

Completed

• Conditions: Central Nervous System (CNS) Demyelinating Disease; Multiple Sclerosis
• Interventions: Biological: BIIB033; Other: Placebo

• Registration Number: NCT02641041
• Lead Sponsor: Biogen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-23
• Study First Posted: 2015-12-29
• Study Start: 2016-02
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-07
• Last Update Posted: 2016-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3	BIIB033	One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15
Cohort 1	Placebo	A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1
Cohort 2	Placebo	A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1
Cohort 1	BIIB033	A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1
Cohort 2	BIIB033	A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1
Cohort 3	Placebo	One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15

Primary Outcome Measures

Name	Time	Method
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)	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 laboratory parameters	Up to day 113
Number of participants with clinically significant neurological examination abnormalities	Up to day 113

Secondary Outcome Measures

Name	Time	Method
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: 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
PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)	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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Leeds, West Yorkshire, United Kingdom