234HV101 - SAD
Research type
Research Study
Full title
A Phase 1 Randomized, Blinded, Placebo-Controlled Study of Single Ascending Doses of BIIB063 in Healthy Volunteers
IRAS ID
181079
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Biogen
Eudract number
2015-001283-18
Duration of Study in the UK
0 years, 10 months, 22 days
Research summary
The Study Drug (BIIB063) is an investigational drug which is being developed with an aim to help people with Primary Sjögren’s syndrome (pSS). pSS is an autoimmune disease; that is, a disease in which the immune system turns against the body’s own cells. There is no treatment available to cure or stop progression of the disease.
This is the first time that the BIIB063 is being given to humans. Study will be blinded (neither the Investigator nor the subject will be aware of treatment assignment) and placebo-controlled (dummy medication for some subjects). This study will be conducted in healthy male and female subjects between 18 and 55 years of age.
58 volunteers will be enrolled in 8 groups. The planned dose levels ranges from 0.003 to 20mg/kg s and medication will be given intravenously (through veins) except for group 8 where medication will be given subcutaneously (under the skin) 150mg/kg .
Volunteers will check into the study site on Day -1 (day before dosing day) and be confined to the study site for 3 days. On Day 1 volunteers will be randomized to receive BIIB063 or placebo and administered a single dose of study medication. Between Day 3 and the Week 1 visit, the Investigator (or qualified designee) will telephone volunteers to check on their well-being. Volunteers will return to the study site for evaluation at 1 week intervals for 4 weeks post dose and at Weeks 6, 8, and 12. The EOS visit will occur no earlier than 12 weeks after administration of study treatment, but may be extended at 2 week intervals up to Week 24 as determined from PK/PD findings from emerging data from previous dose groups..
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0440
Date of REC Opinion
23 Jun 2015
REC opinion
Further Information Favourable Opinion