SAD Phase I Study (First-in-human) to Investigate Contraloid Acetate
Status:
Completed
Trial end date:
2018-07-27
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Prof. Dr. Dieter Willbold
Collaborators:
Fundación Teófilo Hernando, Spain Helmholtz-Gemeinschaft Deutscher Forschungszentren, Germany Medical University of Vienna NeuroScios, Austria Triskelion, The Netherlands