255HV101- SAD and MAD study OF BIIB095
Research type
Research Study
Full title
A Phase 1, Randomized, Double-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB095 in Healthy Subjects
IRAS ID
235757
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Idec Research Ltd
Eudract number
2017-003982-90
Clinicaltrials.gov Identifier
17/LO/1710, REC London Brent
Duration of Study in the UK
0 years, 8 months, 2 days
Research summary
BIIB095 is an IMP being developed for the treatment of chronic pain. BIIB095 works by blockingsodium channels that are important for nerve cells carrying pain sensation to brain.Nonclinical studies in vitro and in vivo animal models have shown that BIIB095 may show efficacy in treating neuropathic pain and could offer a potentially better tolerability profile than currently available treatments. These expectations are based on genetic evidence of the involvement of sodium channel Nav1.7 in pain syndromes, and favorable safety profile of BIIB095 in animal models.
The main purpose of this study are; to assess the safety and tolerability when it is given as single and multiple oral doses to healthy volunteers.
This study will be conducted in 2 parts. Part A will be done as a single dose study, starting with a low dose and subsequent groups getting a higher dose. There will be up to 6 groups in this part. The first two subjects in a group will be dosed 24 hours before the next three subjects get the medication, then the final three subjects will be dosed another 24 hours later.Each group will have 8 volunteers, two will receive placebo (dummy) drug. In cohort 4 a single dose will be administered in a fasted state in period 1 and in a fed state in period 2. In part B, Subjects will receive multiple oral doses of BIIB095or placebo twice daily from Days 1 to 13, and once daily in the morning on Day 14. Morning doses will be preceded by an overnight fast from food and will be followed by a fast from food for at least 2 hours post dose. Evening doses will be preceded by a fast from food of at least 2 hours and will be followed by a fast from food for at least 2 hours post dose.There will be up to 4 groups in this part.REC name
London - Brent Research Ethics Committee
REC reference
17/LO/1710
Date of REC Opinion
10 Jan 2018
REC opinion
Further Information Favourable Opinion