276HV101- BIIB113 in Healthy Participants
Research type
Research Study
Full title
A Phase 1 Randomized, Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With an Open-Label Target Occupancy Study of BIIB113 in Healthy Participants.
IRAS ID
1004272
Contact name
Patricia Andrade
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2021-002903-36
Research summary
The study medicine (BIIB113) is an experimental treatment for Alzheimer’s disease (AD), a progressive serious condition that affects the brain. AD causes problems with memory, judgement, movement and speech, and patients may be confused or have mood swings.
People with AD have a toxic build-up of proteins in the brain, which form tangles. This causes nerve cells in the brain to die and parts of the brain are damaged. We hope that BIIB113 will work by reducing the build-up and tangles of protein in the brain, and by doing so, treat the underlying cause of AD and slow down the onset of severe symptoms.
BIIB113 has never been given to humans before. This study funded by Biogen will evaluate the safety and tolerability of single and multiple ascending doses of BIIB113 in healthy participants (healthy female and sterile/vasectomised male participants). The study comprises 3 parts (Parts A–C) and will start with a small dose and increase as the study progresses . Parts A and B will be conducted at 2 sites in the UK. Part C will be conducted in Sweden.
Part A: Single oral doses of BIIB113 (or placebo) will be tested, fasted, in approximately 45 volunteers aged 18–64. One group (Group 3) will have two study sessions so they can take a second dose with food. Participants will stay on the ward for 4 nights in each session. They’ll take up to 2 weeks to complete the study (or up to 9 weeks if they’re in Group 3).
Part B: Once-daily oral doses of BIIB113 (or placebo) will be tested for 14 days in approximately 27 volunteers aged 18–64 and 9 volunteers aged 65–75. Participants will have 1 study session and stay on the ward for 15 nights. They’ll take up to 3–4 weeks to complete the study.REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0802
Date of REC Opinion
31 Dec 2021
REC opinion
Favourable Opinion