SAD Phase I Study (First-in-human) to Investigate Contraloid Acetate

Summary

This is a single-center first-in-human single-ascending-dose clinical trial assessing the safety and tolerability of oral dosing of Contraloid acetate in healthy volunteers. The study drug Contraloid (alias RD2, alias PRI-002) is an orally available all-D-peptide, which was developed to directly destroy toxic and replicating A-beta oligomer prions, by disassembling them into A-beta monomers. The study drug is specifically designed for the curative or at least disease-modifying treatment of cognition, memory and behavior deficits in Alzheimer´s disease patients. The study drug is not designed to reduce brain plaque load or total A-beta in cerebrospinal fluid. The study drug is blood-brain-barrier penetrable \[1\] and has demonstrated target engagement in vitro and in vivo \[2, 3\]. Preclinical treatments in three different transgenic mouse models in three different laboratories yielded improved cognition and deceleration of neurodegeneration, even under truly non-preventive treatment conditions and even when applied orally \[2-5\]. The hereby obtained PRI-002 plasma levels have also been achieved in humans after single oral dosing.

Timeline

Start

2018-04-09

Primary completion

2018-07-27

Completion

2018-07-27

Drugs

Indications