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

NCT03944460 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-05-09

No results posted yet for this study

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.

Conditions

  • Alzheimer Dementia
  • Alzheimer Disease

Interventions

DRUG

Contraloid

Oral administration of capsules, drug substance or placebo without any excipients.

Sponsors & Collaborators

  • Helmholtz-Gemeinschaft Deutscher Forschungszentren, Germany

    collaborator UNKNOWN

  • Medical University of Vienna

    collaborator OTHER

  • NeuroScios, Austria

    collaborator UNKNOWN

  • Triskelion, The Netherlands

    collaborator UNKNOWN

  • Fundación Teófilo Hernando, Spain

    collaborator OTHER

  • Prof. Dr. Dieter Willbold

    lead OTHER

Principal Investigators

  • Michael Wolzt, MD · University of Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2018-07-27
Completion
2018-07-27

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03944460 on ClinicalTrials.gov