Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
← catalyst calendarNCT06989840 · readout ≤ 165 d
Sponsored by Sagimet Biosciences Inc. (industry) · SGMT — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
128estimated
Sites
2
Countries
Australia, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-06-03 | actual | When the study began enrolling |
| Primary completion | Jan 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2025-05-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-09 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Acne
Interventions
- Drug: TVB-3567
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFPart A - Incidence of adverse events (AEs) and serious adverse events (SAEs)
measured Baseline to 7 to 8 days after dosing
Part B - Plasma AUC0-t in fasted and fed conditions
measured Baseline to Day 4
Part B - Plasma AUC0-inf in fasted and fed conditions
measured Baseline to Day 4
Part B - Plasma Cmax in fasted and fed conditions
measured Baseline to Day 4
Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions
measured Baseline to 7 to 8 days after dosing
Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs)
measured Baseline to 13 to 15 days after the last dose
Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs)
measured Baseline to 13 to 15 days after the last dose
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