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A phase 1/2a first-in-human study of the Alpha-synucleinopathies (ASYN) in Parkinson's Disease (PD) patients

Trial Profile

A phase 1/2a first-in-human study of the Alpha-synucleinopathies (ASYN) in Parkinson's Disease (PD) patients

Status: Planning
Phase of Trial: Phase I/II

Latest Information Update: 06 Jul 2021

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At a glance

  • Drugs AMDX-2011P (Primary)
  • Indications Parkinson's disease
  • Focus Diagnostic use; First in man

Most Recent Events

  • 28 Jun 2021 According to an Amydis media release, the company received an award from the National Institute of Aging (NIA) at National Institutes of Health (NIH).The two-year Commercialization Readiness Pilot (CRP) Program award will provide additional funding toward the preparation and filing of an Investigational New Drug Application (IND) and completion of this FDA-reviewed adaptive study.
  • 30 Apr 2021 New trial record
  • 26 Apr 2021 According to an Amydis media release, the company has completed the pre-IND interaction with the USA Food and Drug Administration for the development plans of this drug. The pre-IND dossier included the design of this study.

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