Clinical Trial

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

Recruiting Phase 1
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 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.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-05-01 -> 2027-01 2026-06-10
minor Completion pushed: 2026-06-01 -> 2027-01 2026-06-10
Trial Details
NCT Number NCT06989840
Lead Sponsor Sagimet Biosciences Inc.
Conditions Acne
Enrollment 128 participants
Start Date 2025-06-03
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-09