Actively Recruiting
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Led by Sagimet Biosciences Inc. · Updated on 2026-02-06
128
Participants Needed
2
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose TVB-3567 administered orally in healthy participants. Parts C and D will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.
CONDITIONS
Official Title
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 55 years
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 for healthy participants
- Medically healthy with no significant medical history
- Able to understand and comply with study procedures
- For participants with acne: BMI between 18.0 and 37.0 kg/m2
- Diagnosed with moderate to severe acne vulgaris
You will not qualify if you...
- History or presence of significant medical or psychiatric conditions
- History of allergic or unusual reaction to the study drug or related acne products
- Clinically significant eye examination findings
- Female participants of childbearing potential
- Use or anticipated use of any medications, topical anti-acne treatments, or certain enzyme-inducing drugs within 28 days before dosing
- For Part C: previous use of tretinoin treatments
- For participants with acne (Part D): prior tretinoin treatments, photoelectric therapy, dermabrasion, chemical peeling, corticosteroid therapy, or significant skin diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Celerion, Inc.
Tempe, Arizona, United States, 85283
Completed
2
Nucleus Network
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
S
Study Director
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here