Kareus Therapeutics SA has announced the start of a Phase I clinical study following the Investigational New Drug (IND) approval from the US Food and Drug Administration for the development of KU-046, a first-in-class disease modifying new chemical entity discovered for the treatment of Alzheimer's disease using Kareus' proprietary bioenergetics and KARLECT platforms.
The Phase I clinical trial is a randomized, double-blind, placebo-controlled two-part study to assess the safety, tolerability and pharmacokinetics of single ascending oral doses and of multiple ascending oral doses of KU-046 in 54 healthy young volunteers. The study is being conducted by Quintiles at its Phase I Unit at Overland Park in Kansas.