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A Phase I/II Study of CMND-100 Tolerability, Safety, and Pharmacokinetics in Healthy Volunteers and Subjects With Alcohol Use Disorder
Led by Clearmind Medicine Inc. · Updated on 2026-03-31
84
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety, tolerability, and how the body processes the investigational drug CMND-100 in both healthy volunteers and people with Alcohol Use Disorder (AUD). The study also aims to explore if CMND-100 can help reduce drinking and craving in those with moderate to severe AUD. This is a Phase I/II trial with multiple parts to carefully evaluate these factors. The study is divided into four parts. Parts A and B involve giving single ascending doses of CMND-100 to healthy volunteers and subjects with AUD, respectively, to assess safety and drug behavior. Parts C and D are randomized and double-blind, where participants receive either CMND-100 or placebo daily for five days to further evaluate safety, drug effects, and preliminary efficacy. Each part includes careful dose escalation guided by a monitoring board. Participants will undergo physical exams, blood sampling for drug levels, and daily safety monitoring during and after dosing. Assessments include observing adverse events and measuring drug concentration in the body up to 31 days. For subjects with AUD in Part D, craving for alcohol will be assessed using specific craving scales. The total involvement includes dosing days and follow-up for safety and pharmacokinetic analysis, lasting up to several weeks.
CONDITIONS
Brief Title
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Understand and agree to follow all study activities
- Age between 18 and 60 years
- Body mass index between 18 and 35 kg/m2 and weight above 60 kg
- No significant health conditions or medications that could affect safety or study results
- Male participants agree to use condoms during the study and for a suitable period after
- Female participants are not pregnant, not breastfeeding, and agree to use effective contraception if of childbearing potential
- For Alcohol Use Disorder subjects: meeting DSM-5 criteria, at least 4 binge drinking days in the past month, desire to reduce or stop drinking
- Stable housing for 3 months before screening and expected stability during the study
- Agree to abstain from new psychotropic medications except benzodiazepines as rescue or continue stable doses prior to enrollment
You will not qualify if you...
- History of diseases or disorders that could affect study results or increase risk
- Current substance use disorders except alcohol use in AUD subjects and nicotine use disorders
- Use of cannabis, other drugs, or nicotine within five half-lives before screening
- Symptoms of alcohol withdrawal or intoxication at screening
- History of seizures or epilepsy
- Major depressive disorder within past year, bipolar disorder, schizophrenia, or recent suicidal ideation or attempts
- Uncontrolled illness such as active infection
- Abnormal vital signs or ECG parameters including QTc >450 msec
- Significant abnormal liver function or other laboratory abnormalities
- Use of certain medications including antipsychotics, mood stabilizers, MAOIs, TCAs, lithium, serotonin-acting supplements, enzyme altering agents, or others that may interact with the study drug
- Recent use of experimental drugs or devices within defined timeframes
- Blood donation within 90 days or plasma donation within 30 days before dosing
- Inability to fulfill study requirements per investigator judgment
- For healthy subjects: inability to abstain from alcohol for 72 hours before dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks depending on dose escalation and monitoring
Healthy volunteers receive a single dose of CMND-100 in ascending dose cohorts. Participants will be sampled for pharmacokinetics (PK) for 24 hours following dosing and monitored for safety daily for 1 week after dosing.
1 dosing visit and daily safety monitoring for 7 days
Duration - Up to 2 weeks depending on dose escalation and monitoring
Subjects with Alcohol Use Disorder receive a single dose of CMND-100 in ascending dose cohorts based on tolerable doses from Part A. Participants will be sampled for PK for 24 hours following dosing and monitored for safety daily for 1 week after dosing.
1 dosing visit and daily safety monitoring for 7 days
Duration - Approximately 2 weeks including treatment and follow-up
Healthy volunteers are randomized to receive daily doses of CMND-100 or placebo for 5 consecutive days. Participants will be sampled for PK for 24 hours after the first and last dosing and monitored daily for safety during treatment and for 1 week after the last dose.
5 daily dosing visits plus daily safety monitoring and 1 week follow-up
Duration - Approximately 2 weeks including treatment and follow-up
Subjects with Alcohol Use Disorder are randomized to receive daily doses of CMND-100 or placebo for 5 consecutive days. Participants will be sampled for PK for 24 hours after the first and last dosing and monitored daily for safety during treatment and for 1 week after the last dose.
5 daily dosing visits plus daily safety monitoring and 1 week follow-up
Trial Site Locations
Total: 4 locations
1
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Actively Recruiting
2
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
3
Hadassah Medical Center
Jerusalem, Israel, 91120
Actively Recruiting
4
Tel-Aviv Sourasky Medical Center (TASMC)
Tel Aviv, Israel, 6423906
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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