215HV102 - SAD+MAD
Research type
Research Study
Full title
A Randomized, Blinded, Placebo-Controlled, Single- and Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects.
IRAS ID
196051
Contact name
Jim Bush
Contact email
Sponsor organisation
Biogen MA Inc.
Eudract number
2015-004560-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
The Study Drug (BIIB033) is an investigational drug which is being developed with the aim of helping people with Multiple Sclerosis (MS), a disease of the nervous system. The study aims to test BIIB033 in healthy adult Japanese subjects. BIIB033 has already been tested in non-Japanese healthy volunteers and in patients.\n\nThis is a double-blind (subjects and the investigator will not know who had the study drug) and placebo (dummy medication) -controlled. Which participants receive BIIB033 or placebo will be determined randomly (3:1 BIIB033 to placebo ratio).\n\nThere will be 3 groups; in each group 8 healthy volunteers (male and female volunteers) will be enrolled. BIIB033 will be administered as an injection through the veins. In Groups 1 and 2, volunteers will receive a single dose of BIIB033 or placebo. In group 3, volunteers will receive 2 doses of BIIB033 or placebo.\n\nVolunteers in groups 1 and 2 will participate in the study for approximately 17 weeks. This includes a 4-week screening period, a 3-day inpatient observation period and a 12-week outpatient observation period.\n\nVolunteers in group 3 will participate in the study for approximately 21 weeks. This includes a 4-week screening period, two 3-day inpatient observation periods, an 11-day outpatient observation period following the first dose and a 14-week outpatient observation period after the last dose. \n\nPlanned dose levels are;\nGroup 1: A single dose of 10 mg/kg \nGroup 2: A single dose of 30 mg/kg \nGroup 3: One dose of 100 mg/kg (on days 1 and 15 – two doses)
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0003
Date of REC Opinion
22 Jan 2016
REC opinion
Further Information Favourable Opinion