A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects With Alcohol Use Disorder (AUD)
Clearmind Medicine Inc.
Summary
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.
Description
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…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugCMND-100
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
Locations (4)
- Connecticut Mental Health CenterNew Haven, Connecticut
- Johns Hopkins Bayview Medical CenterBaltimore, Maryland
- Hadassah Medical CenterJerusalem
- Tel-Aviv Sourasky Medical Center (TASMC)Tel Aviv