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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2016
• Main ID: NCT02641041
• Date of registration: 23/12/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants
• Scientific title: A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects
• Date of first enrolment: February 2016
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02641041
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: 20 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Central Nervous System (CNS) Demyelinating Disease

Intervention(s)

Other: Placebo

Biological: BIIB033

Primary Outcome(s)

Number of participants with clinically significant electrocardiograms (ECGs) abnormalities [Time Frame: Up to day 113]

Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time Frame: Up to day 113]

Number of participants with clinically significant physical examination abnormalities [Time Frame: Up to day 113]

Number of participants with clinically significant laboratory parameters [Time Frame: Up to day 113]

Number of participants with clinically significant neurological examination abnormalities [Time Frame: Up to day 113]

Number of participants with clinically significant vital sign abnormalities [Time Frame: Up to day 113]

Secondary Outcome(s)

PK parameter of BIIB033: AUC over a given dosing interval [Time Frame: Up to day 113]

PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax) [Time Frame: Up to day 113]

Number of participants with positive serum BIIB033 antibodies [Time Frame: 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) [Time Frame: Up to day 113]

PK parameter of BIIB033: Volume of distribution at steady state (Vss) [Time Frame: Up to day 113]

PK parameter of BIIB033: accumulation ratio (RAC) [Time Frame: Up to day 113]

PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf) [Time Frame: Up to day 113]

PK parameter of BIIB033: Maximum observed concentration (Cmax) [Time Frame: Up to day 113]

PK parameter of BIIB033: Terminal elimination half-life (t1/2) [Time Frame: Up to day 113]

PK parameter of BIIB033: Clearance (CL) [Time Frame: Up to day 113]

Secondary ID(s)

2015-004560-11

215HV102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors