TVB-3567 for Acne

Overseen By Study Director

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Sagimet Biosciences Inc.

Must not be taking: CYP3A4 inducers, Corticosteroids

Disqualifiers: Significant medical, Psychiatric, Skin diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

128 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy individuals, some with moderate to severe acne. Participants will be given TVB-3567 or a placebo orally. The study excludes certain people based on undisclosed criteria.

Inclusion Criteria

I am generally healthy with no major medical issues.

Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2

Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol

Exclusion Criteria

Has a clinically significant ophthalmic examination finding

I am a woman who can become pregnant.

I have a serious skin condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Randomized, double-blind, placebo-controlled investigation of single ascending doses to assess safety, tolerability, PK, and PD biomarkers

4 weeks

Multiple visits (in-person)

Food Effect

Open-label, 2-way crossover investigation to assess the effect of food on a single dose

4 days

Multiple visits (in-person)

Multiple Ascending Dose (MAD)

Randomized, double-blind, placebo-controlled investigations of multiple ascending doses to assess safety, tolerability, PK, and PD/biomarkers

4 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• TVB-3567

Trial Overview TVB-3567's safety, tolerability, and effects inside the body are being tested in four parts: single doses with/without food and multiple doses in those without/with acne compared to a placebo.

Participant Groups

Group I: Part D (MAD in Acne Participants) Experimental Treatment 2 Interventions

Group II: Part C (MAD in Healthy Participants) Experimental Treatment 2 Interventions

Group III: Part B (Food Effect) Experimental Treatment 1 Intervention

Group IV: Part A (SAD in Healthy Participants) Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Sagimet Biosciences Inc.

Lead Sponsor

Trials

10

Recruited

3,900+