drugset / Trial / NCT05913752
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
RandomizedSequentialQuadruple-blindTreatment
Summary
The primary objective of this study is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with 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 subjects with moderate to severe AUD.
Timeline
- Start
- 2025-04-30
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 5-methoxy-2-aminoindane | Small molecule | 20 mg | — |
| Subject | 5-methoxy-2-aminoindane | Small molecule | 40 mg | — |
| Subject | 5-methoxy-2-aminoindane | Small molecule | 80 mg | — |
| Subject | 5-methoxy-2-aminoindane | Small molecule | 160 mg | — |