A Study Testing the Safety and Effects of Single Doses of S1-221 in Healthy Volunteers
Status:
NOT_YET_RECRUITING
Trial end date:
2026-02-28
Target enrollment:
Participant gender:
Summary
The purpose of this Phase 1 study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of single ascending doses of S1-221 administered orally to healthy adult participants. S1-221 is a liquid containing cannabidiol (CBD) and 9-tetrahydrocannabinol (THC).
Acute subjective effects will be evaluated as a pharmacodynamic (PD) assessment and changes in plasma endocannabinoid levels will be assessed as an exploratory objective.
Data from this study will be used to select doses to be evaluated in subsequent studies to investigate the efficacy and safety of S1-221 in migraine patients.