Clearmind Medicine Inc.
The primary objective of this study is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with Alcohol Use Disorder (AUD). The secondary objective of this study is to preliminarily evaluate the efficacy of CMND-100 in reduction of drinking patterns and craving in subjects with moderate to severe AUD.
This is a Phase I/II, four-parts study (Parts A to D) in HVs and subjects with AUD, evaluating the tolerability, safety, and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated doses of CMND-100. Parts A and B are open-label, non-controlled parts, in which HVs and subjects with AUD respectively will be treated with single, ascending dose cohorts of CMND-100, for evaluation of tolerability, safety and PK/PD. Parts C and D are randomized, double-blind, placebo-controlled part, in which HVs and subjects with AUD respectively will be treated with repeated doses of CMND-100, for evalu…
Inclusion Criteria: All Subjects * Signed informed consent prior to any study-related procedures, * Subjects understand the nature and the procedures related with the study design of the trial and accept to fulfill all activities related to this trial, * Subjects 18 to 60 years of age, * Body mass index between 18 and 35 kg/m2, with a weight above 60 kg. * No (history of) clinically significant conditions and/or concomitant medications which in the opinion of the investigator could endanger the safety of the subject or impact the validity of the study results, * Male subjects who wish use co…
The investigational product CMND-100 consists of gelatin capsules, each containing the active ingredient (either 20 or 60 mg) 5-methoxy-2-aminoindane (MEAI) and excipients (stabilizers). MEAI is a psychoactive compound of the aminoindane class
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