A Phase I/II Single and Multiple Dose Tolerability, Safety and Pharmacokinetic Study of CMND-100 in Healthy Volunteers and Subjects with Binge Drinking/ Alcohol Use Disorder (AUD)

The primary objective of this four-part study (Part A, B, C and D) is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose CMND-100 in Healthy Volunteers (HV) and participants with Binge Drinking/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 participants with binge drinking or/and moderate to severe AUD.

We are currently only recruiting for Part A of this research study. Part A will enroll healthy volunteers only and will use a single ascending dose in this research. Part A of the study should provide the maximum tolerable dose and early pharmacokinetic data. CMND-100 (the investigational product) is an investigational oral gelatin capsule being developed for the treatment of Alcohol Use Disorder (AUD). CMND-100 is a psychoactive compound with similarity to MDMA (ecstasy). We will discuss this part during consent visit.

Alcohol Use Disorder (AUD) is a medical condition characterized by an impaired ability to stop or control alcohol use despite adverse social, occupational, or health consequences.

Research Study Procedures for part A:

If you are interested in participating in this study and meet the criteria set for Part A, your participation may last approximately 22 days. You will be randomly assigned to either receive CMND-100 or a placebo. On the dosing day, you will have your blood drawn and vitals taken at multiple time points while under 24-hour inpatient monitoring. The dosing day will be video-recorded. Participation involves undergoing a phone screening, informed consent, medical evaluation, and completing the study procedures, as listed below:

• Screening period – this period will last up to 14 days before the start of treatment with CMND-100 or placebo – during this time, your study doctor will assess your medical history and current condition and determine whether you are suitable to participate in the study.

• Treatment period – this period will consist of one treatment day in which you will receive CMND-100 and will last up to 24 hours after receiving CMND-100, when safety parameters and blood levels of the drug will be determined.

• Safety Follow up – this period will last up to one week after CMND-100 administration, and during this period safety parameters will be examined.

You will be requested to present to the Connecticut Mental Health Center three times during the research trial, and for the second visit you will be required to stay at the Connecticut Mental Health Center on the clinical research inpatient unit for approximately 24 hours for close monitoring and frequent blood sample taking to measure blood levels of the product. You will be contacted by phone an additional two times after you are discharged.

Risks Associated with Study Participation:

Risks associated with study participation include anxiety, aggressiveness, sensitivity reactions, tremor, salivation, nausea, diarrhea and mild euphoria and/or “tipsy”. These feelings might be addictive and cause you to want more of CMND-100.

Compensation:

Total estimated compensation is $475.

For more information, please contact study coordinator: Garret Griffith, 203-974-7324.