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

NCT07146945 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

  • Healthy Participants

Interventions

DRUG

S1-221

S1-221 will be administered orally to participants.

DRUG

Placebo

Matching placebo will be administered orally to participants.

DRUG

THC

A single dose of THC will be administered to participants orally.

Sponsors & Collaborators

  • Delphian Therapeutics Australia Pty, Ltd

    lead INDUSTRY

Principal Investigators

  • Ryan Lanier · DelphianTherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2026-02-22
Completion
2026-02-28

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07146945 on ClinicalTrials.gov