A FIH SAD MAD study of ACI-3024
Research type
Research Study
Full title
ACI-3024-1901 – A First-in-human, Randomized, Placebo-controlled, Double-blind, Sequential Single and Multiple Ascending Dose (SAD/MAD) Study with Open-label Food Effect and Pharmacodynamic Assessment Arms to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACI-3024
IRAS ID
263604
Contact name
Sameia Sheikh
Contact email
Sponsor organisation
AC Immune SA
Eudract number
2019-001567-73
Clinicaltrials.gov Identifier
19/LO/0617, REC Reference
Duration of Study in the UK
1 years, 4 months, 9 days
Research summary
ACI-3024 is a new compound under development to treat a set of diseases called tauopathies, of which the most common disease is Alzheimer’s disease. These diseases are caused by a dysfunction in a specific protein in the brain known as Tau. This protein helps electrical signals pass along nerves in the brain. In the Taupathies the protein aggregates into forms which are associated with the damage to nerve cells seen in Alzheimer's disease. ACI-3024 stops and reverses the abnormal aggregation of the tau proteins and reduces their spreading in the brain. The safety and way the drug is handled by the body must be tested in the current study.
This study will take place over three parts, the first part is a single ascending dose study with a food-effect group, which will take part over 5 groups of 8 volunteers, with the exception of the first group all other groups will consist of 4 first generation Japanese volunteers and 4 non-Japanese volunteers (preferred to be non-Asian). The food effect comparison will be in one of the last two groups.
The second part of the study will be 2 single dose groups of healthy male and female volunteers who will have a single dose of ACI-3024 and undergo cerebrospinal fluid sampling in order to assess the CSF pharmacokinetics (how quickly the drug gets cerebrospinal fluid via the blood brain barrier and how quickly it is removed from the body) and pharmacodynamics (how the body is affected by the drug) of ACI-3024.
Part III will be a 2-part multiple ascending dose study, the first part (a) will take part in healthy elderly Japanese or non-Japanese volunteers, the second part (b) will take place in patients with Alzheimer’s disease. Subjects in Parts IIIa and IIIb will undergo magnetic resonance imaging (MRI) of the brain.REC name
London - Brent Research Ethics Committee
REC reference
19/LO/0617
Date of REC Opinion
31 May 2019
REC opinion
Favourable Opinion