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

Primary Purpose

Central Nervous System (CNS) Demyelinating Disease, Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

BIIB033

Placebo

About this trial

This is an interventional basic science trial for Central Nervous System (CNS) Demyelinating Disease focused on measuring Japanese, Single Ascending Dose (SAD), Multiple Ascending Dose (MAD)

Eligibility Criteria

20 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Number of participants with clinically significant laboratory parameters

Number of participants with clinically significant vital sign abnormalities

Number of participants with clinically significant electrocardiograms (ECGs) abnormalities

Number of participants with clinically significant physical examination abnormalities

Number of participants with clinically significant neurological examination abnormalities

Secondary Outcome Measures

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

PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)

PK parameter of BIIB033: AUC over a given dosing interval

PK parameter of BIIB033: Maximum observed concentration (Cmax)

PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)

PK parameter of BIIB033: Terminal elimination half-life (t1/2)

PK parameter of BIIB033: Volume of distribution at steady state (Vss)

PK parameter of BIIB033: Clearance (CL)

PK parameter of BIIB033: accumulation ratio (RAC)

Number of participants with positive serum BIIB033 antibodies

Full Information

NCT ID

NCT02641041

First Posted

December 23, 2015

Last Updated

October 7, 2016

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT02641041

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Nervous System (CNS) Demyelinating Disease, Multiple Sclerosis

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

BIIB033

Intervention Description

single or multiple dose

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

single or multiple dose

Primary Outcome Measure Information:

Title

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time Frame

Up to day 113

Title

Number of participants with clinically significant laboratory parameters

Time Frame

Up to day 113

Title

Number of participants with clinically significant vital sign abnormalities

Time Frame

Up to day 113

Title

Number of participants with clinically significant electrocardiograms (ECGs) abnormalities

Time Frame

Up to day 113

Title

Number of participants with clinically significant physical examination abnormalities

Time Frame

Up to day 113

Title

Number of participants with clinically significant neurological examination abnormalities

Time Frame

Up to day 113

Secondary Outcome Measure Information:

Title

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

Time Frame

Up to day 113

Title

PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)

Time Frame

Up to day 113

Title

PK parameter of BIIB033: AUC over a given dosing interval

Time Frame

Up to day 113

Title

PK parameter of BIIB033: Maximum observed concentration (Cmax)

Time Frame

Up to day 113

Title

PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)

Time Frame

Up to day 113

Title

PK parameter of BIIB033: Terminal elimination half-life (t1/2)

Time Frame

Up to day 113

Title

PK parameter of BIIB033: Volume of distribution at steady state (Vss)

Time Frame

Up to day 113

Title

PK parameter of BIIB033: Clearance (CL)

Time Frame

Up to day 113

Title

PK parameter of BIIB033: accumulation ratio (RAC)

Time Frame

Up to day 113

Title

Number of participants with positive serum BIIB033 antibodies

Time Frame

Up to day 113

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS2 9LH

Country

United Kingdom

12. IPD Sharing Statement

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

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