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RECRUITING

NCT06989840

PHASE1

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.

View on ClinicalTrials.gov

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 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2025-06-03

Completion Date

2027-02

Last Updated

2026-10-21

Healthy Volunteers

Yes

Conditions

Acne

Interventions

DRUG

TVB-3567

Orally administered capsule

DRUG

Placebo

Orally administered capsule

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

Locations (6)

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