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

NCT02641041 | Completed Phase 1

• 2 other identifiers: 215HV1022015-004560-11
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System (CNS) Demyelinating Disease; Multiple Sclerosis

Keywords

Japanese; Single Ascending Dose (SAD); Multiple Ascending Dose (MAD)

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• 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

Study Arms (3)

Cohort 1

EXPERIMENTAL

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

Biological: BIIB033; Other: Placebo

Cohort 2

EXPERIMENTAL

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

Biological: BIIB033; Other: Placebo

Cohort 3

EXPERIMENTAL

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

Biological: BIIB033; Other: Placebo

Interventions

BIIB033 BIOLOGICAL

single or multiple dose

Cohort 1; Cohort 2; Cohort 3

Placebo OTHER

single or multiple dose

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Conditions

Demyelinating Diseases; Multiple Sclerosis

Interventions

opicinumab

Condition Hierarchy (Ancestors)

Nervous System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 29, 2015
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 10, 2016

Record last verified: 2016-10

Locations

GB (1)