Actively Recruiting
Phase 1 Study Evaluating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TVB-3567 in Healthy Adults With or Without Acne, Including Food Effect Assessment
Led by Sagimet Biosciences Inc. · Updated on 2026-02-06
128
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying TVB-3567, an orally administered capsule, in healthy adults with and without moderate to severe acne. This Phase 1 trial aims to assess the safety, tolerability, how the drug is processed in the body (pharmacokinetics), and its effects on biological markers (pharmacodynamics). The study includes four parts that investigate different dosing strategies and the impact of food on the drug. The study has four parts: Part A tests single ascending doses of TVB-3567 in a randomized, double-blind, placebo-controlled setting; Part B evaluates the effect of food on a single dose using an open-label crossover design; Parts C and D assess multiple ascending doses in healthy participants without acne and those with moderate to severe acne, respectively, both in randomized, double-blind, placebo-controlled formats. Participants receive oral capsules of TVB-3567 or placebo. Participants will be monitored for adverse events and serious adverse events after dosing. Key measurements include drug levels in the blood under different conditions and the safety profile over time. The study involves follow-up periods ranging from a few days to about two weeks after dosing. Participants will undergo medical assessments and provide health information to help researchers understand the drug's effects and safety.
CONDITIONS
Brief 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 male or female 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 (only for acne group)
You will not qualify if you...
- History or presence of significant medical or psychiatric conditions
- History of hypersensitivity or unusual reactions to the study drug or related compounds
- Clinically significant findings in eye exams
- Female participants of childbearing potential
- Unable to avoid use of any medications, topical anti-acne treatments, or drugs affecting certain enzymes starting 28 days before dosing
- For healthy participants in Part C: previous tretinoin treatments
- For acne participants: previous tretinoin treatments, photoelectric therapy, dermabrasion, chemical peeling, corticosteroid therapy
- Significant skin diseases (for acne participants)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 days depending on the study part
Participants receive oral capsules of TVB-3567 or placebo to evaluate safety, tolerability, and pharmacokinetics.
Multiple visits during dosing and up to 15 days after the last dose
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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