Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 111

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 111
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 in the study at the following timepoints:

  (i)      Phase 1 - before dosing and at multiple time points (at 0.25, 0.5, 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 18.0 and 24-hour post drug administration.  

  (ii)      Phase 2 - before the first dosing and at multiple time points (at 0.25, 0.5, 1.0, 2.0, 4.0, 6.0, 8.0, 12.0, 18.0 and, 24-hour post drug administration and before the last dosing and at multiple...  

The primary objective of the study is the evaluation
of tolerability, safety and pharmacokinetics of CMND-100 in both healthy and subjects with binge drinking/AUD. Safety will be assessed
from randomization of subjects until the last follow-up visit.

The primary safety endpoint will therefore consist
of evaluation of incidence of adverse events, changes in vital signs, clinical significant abnormal laboratory data, clinical significant
abnormal physical examination and ECG following subject randomization. Additional safety assessments include, among others, abuse liability
measured by Visual Analogue Scale (VAS) and suicide risk assessment measured by the Columbia-Suicide Severity Rating Scale (CSSRS).

The primary PK endpoint parameters will be evaluated
in all subjects: Tmax, Cmax, AUC0-∞, t1/2, Cl, Vd.

Treating Unmet Mental Health Disorders

We believe that AUD is not being addressed by most
of the psychedelic industry. Global spending necessitated by the implications of AUD is sky-rocketing; in 2010 there was an estimated
cost of nearly $250 billion in the United States, comprised of costs due to productivity losses, healthcare expenditures, crime, and traffic
crashes among other things. A 2020 survey in the United States conducted by the National Survey on Drug Use and Health showed that 28.3
million people aged 12 years and older reported having AUD, with 2.1 million of this group having reported receiving treatment for alcohol
use. Despite the pressing need to address AUD, psychedelic industry is mostly focusing on research and development on other areas of health.
We believe that these unmet needs exist across efficacy, safety and time to onset of current treatment