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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641041
• Other study ID #: 215HV102
• Secondary ID: 2015-004560-11
• Status: Completed
• Phase: Phase 1
• First received: December 23, 2015
• Last updated: October 7, 2016
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Central Nervous System (CNS) Demyelinating Disease
• Demyelinating Diseases
• Multiple Sclerosis

Intervention

Biological:
• BIIB033
single or multiple dose

Other:
• Placebo
single or multiple dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to day 113	No
Primary	Number of participants with clinically significant laboratory parameters		Up to day 113	No
Primary	Number of participants with clinically significant vital sign abnormalities		Up to day 113	No
Primary	Number of participants with clinically significant electrocardiograms (ECGs) abnormalities		Up to day 113	No
Primary	Number of participants with clinically significant physical examination abnormalities		Up to day 113	No
Primary	Number of participants with clinically significant neurological examination abnormalities		Up to day 113	No
Secondary	PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)		Up to day 113	No
Secondary	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	No
Secondary	PK parameter of BIIB033: AUC over a given dosing interval		Up to day 113	No
Secondary	PK parameter of BIIB033: Maximum observed concentration (Cmax)		Up to day 113	No
Secondary	PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)		Up to day 113	No
Secondary	PK parameter of BIIB033: Terminal elimination half-life (t1/2)		Up to day 113	No
Secondary	PK parameter of BIIB033: Volume of distribution at steady state (Vss)		Up to day 113	No
Secondary	PK parameter of BIIB033: Clearance (CL)		Up to day 113	No
Secondary	PK parameter of BIIB033: accumulation ratio (RAC)		Up to day 113	No
Secondary	Number of participants with positive serum BIIB033 antibodies		Up to day 113	No