Clinical Trial

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

Not Yet Recruiting Phase 1
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Record status
This record was last updated August 28, 2025 (before its estimated February 22, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07146945
Lead Sponsor Delphian Therapeutics Australia Pty, Ltd
Conditions Healthy Participants
Enrollment 84 participants
Start Date 2025-08-30
Primary Completion 2026-02-22 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-08-28