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NCT Number: NCT06989840

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

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.

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network, Melbourne, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study:

  • BMI ≥18.0 and ≤37.0 kg/m2.
  • Must be diagnosed with moderate to severe acne vulgaris

Exclusion criteria

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)

Participants must not be enrolled if they do not meet any of the above criteria, as well as the following exclusion criteria:

  • 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

Treatment and study plan

TVB-3567

Drug

Orally administered capsule

Placebo

Drug

Orally administered capsule

Primary outcomes

  1. Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Baseline to 7 to 8 days after dosing

  2. Part B - Plasma AUC0-t in fasted and fed conditions

    Time frame: Baseline to Day 4

    Area under the concentration-time curve from time zero until the last observed concentration

  3. Part B - Plasma AUC0-inf in fasted and fed conditions

    Time frame: Baseline to Day 4

    Area under the concentration-time curve from time zero to infinity

  4. Part B - Plasma Cmax in fasted and fed conditions

    Time frame: Baseline to Day 4

    Maximum concentration measurement in plasma

  5. Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions

    Time frame: Baseline to 7 to 8 days after dosing

  6. Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Baseline to 13 to 15 days after the last dose

  7. Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Baseline to 13 to 15 days after the last dose

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

(650) 561-8600

Sponsors and collaborators

Lead sponsor

Sagimet Biosciences Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 25, 2025
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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