MAD Phase I Study to Investigate Contraloid Acetate
Status:
Completed
Trial end date:
2019-04-03
Target enrollment:
Participant gender:
Summary
This is a single-center multiple-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 BBB penetrable [1] and has demonstrated target engagement
in vitro and in vivo [2, 3]. 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.
Phase:
Phase 1
Details
Lead Sponsor:
Prof. Dr. Dieter Willbold
Collaborators:
Alzheimer's Association Fundación Teófilo Hernando, Spain Helmholtz-Gemeinschaft Deutscher Forschungszentren, Germany Medical University of Vienna NeuroScios, Austria Nuvisan, Germany