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A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects With Binge Drinking/ Alcohol Use Disorder (AUD )

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Trial Profile

A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects With Binge Drinking/ Alcohol Use Disorder (AUD )

Status: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 Mar 2024

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At a glance

  • Drugs 5 methoxy 2 aminoindane (Primary)
  • Indications Alcoholism
  • Focus Adverse reactions; First in man; Pharmacodynamics; Pharmacokinetics
  • Sponsors Clearmind Medicine
  • Most Recent Events

    • 13 Mar 2024 According to a Clearmind Medicine media release, company intends to have two additional sites in the United States for this phase I/IIa clinical trial, at the Yale School of Medicines Department of Psychiatry and the Johns Hopkins University School of Medicine.
    • 23 Feb 2024 According to a Clearmind Medicine media release, the company has received approval from the Ministry of Health of Israel to commence its phase I/IIa clinical trial for alcohol use disorder (AUD) patients using the company's proprietary MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule.
    • 19 Jan 2024 Given protocol has been amended as above-1) Number of treatment arms has been changed from 3 to 4. 2) sequential assignment has been amended. 3) Planned initiation date changed from 1 Sep 2023 to 1 Apr 2024.
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