Bookmarks
ID 322: Extension: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics, With Target Occupancy Study of BIIB113 in Healthy Participants.
Safe People
Organisation name
Imperial College Health Partners (ICHP)
Applicant name(s)
Funders/ Sponsors
Safe Projects
Project ID
ID 322
Lay summary
This is a phase 1 Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study which aims to evaluate the Safety, Tolerability, and Pharmacokinetics in healthy participants of an experimental new medicine for treating AD.
Public benefit statement
This is a phase 1 Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study which aims to evaluate the Safety, Tolerability, and Pharmacokinetics in healthy participants of an experimental new medicine for treating AD. It has never been given to humans before. 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 the study medicine will work by reducing the build-up and tangles of protein in the brain. By doing that, we hope the study medicine will treat the underlying cause of AD and slow down the onset of severe symptoms. The healthy population in North West London will be able to support medical research in Alzheimer’s disease. There is also an additional benefit of having a general health check up and 24/7 medical attention
Other approval committees
Latest approval date
13/04/2023
Safe Data
Dataset(s) name
Safe Setting
Access type
TRE