Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Recruiting
Phase 1
Interventional Study
Acne
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 128 (estimated)
- Sponsor
- Sagimet Biosciences Inc. · Industry
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About This Trial
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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Healthy Participants (Parts A, B and C)
1. Healthy, adult, male or female 18-55 years of age
2. Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2
3. Medically healthy with no clinically significant medical history
4. Understands the study procedures in the informed consent form (ICF)…
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