RecruitingPhase 1

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

United States, Australia128 participantsStarted 2025-06-03

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline to 7 to 8 days after dosing

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

Timeframe: Baseline to Day 4

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

Timeframe: Baseline to Day 4

Part B - Plasma Cmax in fasted and fed conditions

Timeframe: Baseline to Day 4

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

Timeframe: Baseline to 7 to 8 days after dosing

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

Timeframe: Baseline to 13 to 15 days after the last dose

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

Timeframe: Baseline to 13 to 15 days after the last dose

Trial details

NCT IDNCT06989840

SponsorSagimet Biosciences Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Study Director

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

View on ClinicalTrials.gov More Acne trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

What they're measuring

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

Timeframe: Baseline to 7 to 8 days after dosing

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

Timeframe: Baseline to Day 4

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

Timeframe: Baseline to Day 4

Part B - Plasma Cmax in fasted and fed conditions

Timeframe: Baseline to Day 4

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

Timeframe: Baseline to 7 to 8 days after dosing

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

Timeframe: Baseline to 13 to 15 days after the last dose

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

Timeframe: Baseline to 13 to 15 days after the last dose