RECRUITING Phase 1 ClinicalTrials.gov

Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne

Sponsor: Sagimet Biosciences Inc. • ClinicalTrials.gov ID: NCT06989840

Registry updated: 2026-10-21

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Description

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 an open-label, 2-way crossover investigation to assess the effect of food on a single dose of TVB-3567 administered orally in healthy participants. Part C will be a randomized, double-blind, placebo-controlled investigation of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants. Part D will be an open-label investigation of two doses of TVB-3567 across two cohorts, to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants with moderate to severe acne.

Interventions

TVB-3567 (Drug)
Orally administered capsule
Placebo (Drug)
Orally administered capsule

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) and willing and able to comply with the protocol Healthy Participants with Acne (Part D only) Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study: 1. BMI ≥18.0 and ≤37.0 kg/m2. 2. Must be diagnosed with moderate to severe acne vulgaris Exclusion Criteria: Healthy Participants (Parts A, B and C) 1. History or presence of clinically significant medical or psychiatric condition or disease 2. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products. 3. Has a clinically significant ophthalmic examination finding 4. Female participant of childbearing potential 5. 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) Participants must not be enrolled if they do not meet any of the above criteria, as well as the following exclusion criteria: 1. Unable to refrain from or anticipates the use of: * Any topical prescription or non-prescription anti-acne cleansers or treatments on the face, beginning 14 days prior to the first dosing. * Tretinoins, including tazarotene, adapalene, trifarotene, tretinoin, photodynamic therapy, dermabrasion, or chemical peeling (on the face) beginning 4 weeks prior to the first dosing. * Oral retinoid (isotretinoin) therapy beginning 6 months prior to the first dosing. 2. Significant skin diseases

Conditions

Acne

Locations

Celerion, Inc. — Tempe, Arizona, United States
Emeritus Research — Botany, New South Wales, Australia
The Skin Hospital — Darlinghurst, New South Wales, Australia
Emeritus Research — Camberwell, Victoria, Australia
Nucleus Network — Melbourne, Victoria, Australia
Fremantle Dermatology — Fremantle, Western Australia, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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