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

NCT06989840 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SB3567-CLIN-001
• Study Type: interventional
• Target: 128
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Acne

Outcome Measures

Primary Outcomes (7)

• 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

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

  Baseline to Day 4

• Part B - Plasma AUC0-inf in fasted and fed conditions

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

  Baseline to Day 4

• Part B - Plasma Cmax in fasted and fed conditions

  Maximum concentration measurement in plasma

  Baseline to Day 4

• 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

Study Arms (4)

Part A (SAD in Healthy Participants)

EXPERIMENTAL

Drug: TVB-3567; Drug: Placebo

Part B (Food Effect)

EXPERIMENTAL

Drug: TVB-3567

Part C (MAD in Healthy Participants)

EXPERIMENTAL

Drug: TVB-3567; Drug: Placebo

Part D (MAD in Acne Participants)

EXPERIMENTAL

Drug: TVB-3567; Drug: Placebo

Interventions

TVB-3567 DRUG

Orally administered capsule

Part A (SAD in Healthy Participants); Part B (Food Effect); Part C (MAD in Healthy Participants); Part D (MAD in Acne Participants)

Placebo DRUG

Orally administered capsule

Part A (SAD in Healthy Participants); Part C (MAD in Healthy Participants); Part D (MAD in Acne Participants)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sagimet Biosciences Inc.: lead

Study Sites (2)

Celerion, Inc.

Tempe, Arizona, 85283, United States

COMPLETED

Nucleus Network

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Central Study Contacts

Study Director

CONTACT

(650) 561-8600; SB3567-CLIN-001@sagimet.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: June 3, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

US (1); AU (1)