08:58 AM EDT, 03/13/2024 (MT Newswires) -- Clearmind Medicine Inc. ( CMND ) has received approval from the Israeli Ministry of Health to begin 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. The approval, previously announced on February 23, 2024, allows Clearmind to start its clinical trial.

The trial is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and AUD subjects. The Israeli study will be led by Prof. Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan.

The company intends to have two additional sites in the US for the phase I/IIa clinical trial, at the Yale School of Medicine's Department of Psychiatry and the Johns Hopkins University School of Medicine.

The primary endpoint of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics of single and repeated doses of CMND-100 in healthy subjects and those with AUD. The secondary endpoint is to evaluate the preliminary efficacy of CMND-100 in reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD. Oral capsules will be administered and subjects treated by these oral capsules will report their drinking patterns and cravings for alcohol during the clinical trial.