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

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Sagimet Biosciences Inc.
Study ID
NCT06989840
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Acne

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • TVB-3567 — DRUG
    Orally administered capsule
  • Placebo — DRUG
    Orally administered capsule

Study Details

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.

Key Dates

Start date
Jun 3, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
128 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A (SAD in Healthy Participants)
  • Experimental: Part B (Food Effect)
  • Experimental: Part C (MAD in Healthy Participants)
  • Experimental: Part D (MAD in Acne Participants)

Primary Outcome Measure

Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Baseline to 7 to 8 days after dosing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion, Inc.TempeArizona85283-

Find similar trials in Tempe, AZ

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Celerion, Inc.· Tempe, AZ

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