Clearmind Medicine Inc. (NASDAQ: CMND) announced positive safety results from Part A of its ongoing FDA-regulated Phase I/II clinical trial evaluating CMND-100, an oral drug candidate for the treatment of Alcohol Use Disorder (AUD).

All 24 participants enrolled across four ascending-dose cohorts completed treatment as planned. The study met its primary endpoint of safety and tolerability. No serious adverse events were observed across any cohort, including at the highest dose level tested.

Part A used a sequential single-ascending-dose design, with cohorts of six healthy volunteers each receiving approximately 20 mg, 40 mg, 80 mg, or 160 mg of CMND-100. The company stated that tolerability remained consistent across all dose levels.

"Successfully completing the full dose-escalation sequence in Part A with a consistently favorable safety and tolerability profile—including at the highest dose level—represent a significant milestone for the program," said Adi Zuloff-Shani, PhD, CEO of Clearmind Medicine.

The multicenter trial is being conducted under FDA oversight at sites in the United States and Israel, including Yale School of Medicine, Johns Hopkins University School of Medicine, Tel Aviv Sourasky Medical Center, and Hadassah Medical Center.

Clearmind stated it is completing its assessment of the full Part A dataset and intends to progress to subsequent stages of the clinical program, including dosing patients with AUD, assuming continued favorable findings.

CMND-100 is based on MEAI (5-methoxy-2-aminoindane) and is described by the company as a non-hallucinogenic compound intended to promote neuroplasticity without the perceptual effects associated with classical psychedelics.