Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CMND-100 · 1 trial · 1 indication
Incidence of adverse events and classification in terms of severity, causality and outcome
Time to maximum plasma concentration
Maximum plasma concentration
Area under the concentration-time curve from 0 minutes extrapolated to infinity
Terminal elimination phase half-life expressed in time units
The volume of plasma cleared of the drug per unit time
The volume in which a drug is distributed
| Arm | Type | Description |
|---|---|---|
| Healthy Subjects - Part A | OTHER | Part A: Single dose (\~ 24 ) Healthy Volunteers: At least four consecutive ascending dose cohorts (20 mg, 40, 80 and 160 mg) will be included in this part of the study in accordance with a pre-defined dose escalating scheme. In each cohort, 6 HVs will receive a single dose of investigation medicine product (CMND-100) starting with the lowest dose of 20 mg. Once dosed, the subjects will be sampled for PK for 24 hours following dosing and will be monitored for drug effects with a physical examination at the end of 24 hours after dosing and daily monitored for safety for a period of 1 week following dosing. Assuming no serious adverse reactions or limiting toxicity (grade 2 and higher) in up to 2, subjects are observed in this dose level, then the next 6 subjects are treated with the next escalated dose, in accordance with a pre-defined dose escalating scheme. The DSMB will review results after each cohort and guide doses to be studied in Parts B, C and D. |
| AUD Subjects - Part B | OTHER | Single dose (\~12): After DSMB review of part A, AUD subjects will be enrolled in at least 2 consecutive ascending single dose cohorts using the highest tolerable doses from Part A. The first cohort (n=6) will start with the lower ascending dose and sampled for PK for 24 hours following dosing and will be monitored for drug effects with a physical examination at the end of 24 hours after dosing and daily monitored for safety for a period of 1 week following dosing. Assuming no serious adverse reactions or limiting toxicity are observed in this dose level, then the next 6 subjects are treated with the next escalated dose. At the end of this part, real time PK data from the dose cohorts will be collected and analyzed. PK and safety information from this part of the study and from Part A will be reviewed by the DSMB and will guide the dose to be studied in Part D. |
| AUD Subjects - Part C | PLACEBO_COMPARATOR | Multiple dose (18) HVs: Once Part A has been completed, the data analysed and approved by the DSMB, Part C will be initiated. This part will consist of a repeated-dose cohort based on the higher tolerable dose found in Part A. HVs will be randomized into either the treatment or the placebo arm at a ratio of 2:1 (12 subjects treated with the investigation product and 6 subjects receiving placebo) and will receive the drug/placebo at a daily basis for a total of 5 consecutive days. Each subject will be sampled for PK for 24 hours after first and last dosing and will be daily monitored for drug effects and safety throughout the study period and until 1 week after the last dosing. Real time PK data will be collected and results analysed (as defined in Section 5.2). The PK and safety information gathered from in this part of the study will be evaluated by the DSMB and will guide the dose to be studied in Part D of this study. |
| AUD Subjects - Part D | OTHER | Multiple dose (18) subjects with AUD: Once Part B and Part C has been completed, the data analyzed and approved by the DSMB, Part D will be initiated. This part will consist of a repeated-dose cohort, based on the higher tolerable dose found in Part C and considering the dose effects found in Part B. Subjects will be randomized into either the treatment or the placebo arm at a ratio of 2:1 (12 subjects treated with the investigation product and 6 subjects receiving placebo) and will receive the drug/placebo at a daily basis for a total of 5 consecutive days. Each subject will be sampled for PK for 24 hours after first and last dosing and will be daily monitored for drug effects and safety throughout the study period and until 1 week after the last dosing. The PK and safety information gathered from in this part of the study will be evaluated by the DSMB. |
| Name | Type | Description |
|---|---|---|
| CMND-100 | DRUG | 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 |
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...
CMND-100 is an investigational small molecule being developed for the treatment of Alcohol Use Disorder (AUD). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in a first-in-human trial that includes both healthy subjects and those with AUD.
The molecular target of CMND-100 has not been disclosed in the available information. As a small molecule, it is designed to interact with biological pathways relevant to Alcohol Use Disorder, but the specific mechanism of action is not publicly detailed at this time.
CMND-100 is being developed by Clearmind Medicine Inc., a biopharmaceutical company publicly traded under the ticker symbol CMND. The company is conducting a Phase 1 clinical trial of CMND-100 for Alcohol Use Disorder in the United States and Israel.
CMND-100 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 1 trial is a first-in-human study designed to evaluate the safety and tolerability of CMND-100 in healthy volunteers and subjects with Alcohol Use Disorder.
CMND-100 is being evaluated in a single Phase 1 clinical trial registered as NCT05913752, titled "A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects." The trial is currently recruiting participants, with an enrollment target of 84 subjects, and is being conducted at sites in the United States and Israel.
No alternative names for CMND-100 have been disclosed in the available information. The drug is identified solely by its code name CMND-100 in the clinical trial registry and in communications from its developer, Clearmind Medicine Inc.