Clinical trial NCT02641041: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Central Nervous System (CNS) Demyelinating Disease
Multiple Sclerosis
Keywords: Japanese
Single Ascending Dose (SAD)
Multiple Ascending Dose (MAD)
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to day 113
measure: Number of participants with clinically significant laboratory parameters
timeFrame: Up to day 113
measure: Number of participants with clinically significant vital sign abnormalities
timeFrame: Up to day 113
measure: Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
timeFrame: Up to day 113
measure: Number of participants with clinically significant physical examination abnormalities
timeFrame: Up to day 113
measure: Number of participants with clinically significant neurological examination abnormalities
timeFrame: Up to day 113
Secondary outcomes:
measure: PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: Up to day 113
measure: PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
timeFrame: Up to day 113
measure: PK parameter of BIIB033: AUC over a given dosing interval
timeFrame: Up to day 113
measure: PK parameter of BIIB033: Maximum observed concentration (Cmax)
timeFrame: Up to day 113
measure: PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)
timeFrame: Up to day 113
measure: PK parameter of BIIB033: Terminal elimination half-life (t1/2)
timeFrame: Up to day 113
measure: PK parameter of BIIB033: Volume of distribution at steady state (Vss)
timeFrame: Up to day 113
measure: PK parameter of BIIB033: Clearance (CL)
timeFrame: Up to day 113
measure: PK parameter of BIIB033: accumulation ratio (RAC)
timeFrame: Up to day 113
measure: Number of participants with positive serum BIIB033 antibodies
timeFrame: Up to day 113
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Research Site
state: West Yorkshire
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: