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Clinical Trials in the USA / NCT06989840
Recruiting Phase 1

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

NCT06989840 · tracked via the Priya Life Science USA tracker
Sponsor
Sagimet Biosciences Inc
Phase
Phase 1
Started
2025-06-03
Last updated
2026-10-21

Condition(s) studied

Acne

Investigational drug(s) / intervention(s)

TVB-3567Placebo

TVB-3567: Orally administered capsule

Placebo: Orally administered capsule

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs) — Baseline to 7 to 8 days after dosing
  • Part B - Plasma AUC0-t in fasted and fed conditions — Baseline to Day 4
    Area under the concentration-time curve from time zero until the last observed concentration
  • Part B - Plasma AUC0-inf in fasted and fed conditions — Baseline to Day 4
    Area under the concentration-time curve from time zero to infinity
  • Part B - Plasma Cmax in fasted and fed conditions — Baseline to Day 4
    Maximum concentration measurement in plasma
  • Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions — Baseline to 7 to 8 days after dosing
  • Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs) — Baseline to 13 to 15 days after the last dose
  • Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs) — Baseline to 13 to 15 days after the last dose

Trial sites (6)

FacilityCityRegionStatus
Celerion, Inc. Tempe Arizona Completed
Emeritus Research Botany New South Wales Recruiting
The Skin Hospital Darlinghurst New South Wales Not Yet Recruiting
Emeritus Research Camberwell Victoria Recruiting
Nucleus Network Melbourne Victoria Completed
Fremantle Dermatology Fremantle Western Australia Recruiting

More Sagimet Biosciences Inc. trials in the USA

Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA) Recruiting

Other trials for the same condition

Clinical Study to Evaluate the Safety and Efficacy of Candela Technology Active, not recruiting
Exploring Acne Treatments Through Clinical Research Participation Starting soon
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Adults With Moderate to Severe Acne Recruiting
AVAVA MIRIA General Use Recruiting
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06989840 on ClinicalTrials.gov ↗ ← All trials in the USA