Study of CMND-100 Safety, Dosing, and Effects in Healthy Adults and Adults With Alcohol Use Disorder

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 III 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.

A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects