A Study Testing the Safety and Effects of Single Doses of S1-221 in Healthy Volunteers

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 Δ9-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.

Timeline

Start

2025-08-30

Primary completion

2026-02-22

Completion

2026-02-28

Drugs

Indications

No indication recorded.