Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TVB-3567 in Healthy Participants With or Without Acne and to Assess the Effect of Food in Healthy Participants
Sagimet Biosciences Inc.
128 participants
Jun 3, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria8
- Healthy Participants (Parts A, B and C)
- Healthy, adult, male or female 18-55 years of age
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2
- Medically healthy with no clinically significant medical history
- Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol
- Healthy Participants with Acne (Part D only)
- BMI ≥18.0 and ≤37.0 kg/m2.
- Must be diagnosed with moderate to severe acne vulgaris
Exclusion Criteria16
- Healthy Participants (Parts A, B and C)
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products.
- Has a clinically significant ophthalmic examination finding
- Female participant of childbearing potential
- Unable to refrain from or anticipates the use of:
- Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements
- Any topical anti-acne treatment on the face
- Any drugs known to be moderate or strong inducers of CYP3A4 enzymes, BCRP, and/or P gp, including St. John's Wort, beginning 28 days prior to the first dosing.
- Part C only: Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all-trans retinoic acid.
- Healthy Participants with Acne (Part D only)
- Unable to refrain from or anticipates the use of:
- Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all trans retinoic acid.
- Photoelectric therapy, dermabrasion, or chemical peeling
- Intra-articular and systemic corticosteroid therapy
- Significant skin diseases
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Orally administered capsule
Orally administered capsule
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06989840