Company: CMND
Filing Date: 2025-01-22
Form Type: 20-F
Source: 0001213900-25-005490
Chunk: 110

Company: Clearmind Medicine Inc.
Filing Date: 2025-01-22
Form: 20-F
Item: Item 4
Chunk 110
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 is responsible for the global clinical supply chain of CMND-100 from manufacture to the various clinical sites. IMP is
known for its comprehensive, tailor-made clinical supply services that address all study requirements. The array of services to be performed
are fully compliant with GMP, GCP, and GDP standards. Clinical drug supply is a critical factor for trial success so collaboration with
best-in-class clinical drug supply vendor forestalls the possibility of it being a bottleneck to successful drug delivery. Moreover, it
can also deliver enormous benefits, including better investigator and patient experiences as well as cost savings in clinical drug supply.

The Phase I part of the Phase I/IIa clinical study
is an open label, randomized study to evaluate the safety and pharmacokinetics of single ascending doses of MEAI oral capsules. In the
study we are utilizing a hybrid model where we study the effects of MEAI in healthy volunteers and AUD patients. Single ascending doses
will be distributed in up to 4 cohorts, with 6 subjects per dose. s As the study moves forward, we will determine the distribution of
the cohorts based, among other things, on the rate in which we can enroll patients at each site.

The Phase IIa part of the Phase I/IIa clinical
study is a double-blind, randomized,, placebo-controlled study to assess the safety of multiple doses of MEAI in healthy volunteers and
AUD subjects and as a secondary endpoint, the potential effect of MEAI on drinking patterns and cravings in individuals with AUD in accordance
with DSM-V criteria. Two cohorts of 18 subjects per cohort will be given the highest tolerated doses and placebo (2:1 ratio). Oral capsules
will be given once daily, for five consecutive days. The patients will complete diaries and questionnaires to report on their drinking
patterns and craving for alcohol during the clinical trial period.

We will be using a Pharmacokinetics, or PK, assessment
in both phases of the Phase I/IIa study. PK is defined by the American Society of Health-System Pharmacists as the study of the time course
of a drug absorption, distribution, metabolism, and excretion in animals and human. Typical PK assessments include blood and organs collections
at standard time intervals in order to test the drug level in the various tissues as function of time. The pharmacokinetic information
as studied in animals has application to the safe and effective therapeutic management of drugs in an individual patient. In our study,
our PK assessment will consist of collecting blood from all subjects enrolled