A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TVB-3567 in Healthy Participants With or Without Acne and to Assess the Effect of Food in Healthy Participants

Sagimet Biosciences Inc.

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.

Eligibility

Age range: 18–55 years
Sex: All
Healthy volunteers: Yes

Detailed criteria

Inclusion Criteria: Healthy Participants (Parts A, B and C) 1. Healthy, adult, male or female 18-55 years of age 2. Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 3. Medically healthy with no clinically significant medical history 4. Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol Healthy Participants with Acne (Part D only) Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study: 1. BMI ≥18.0 and ≤37.0 kg/m2. 2. Must be diagnosed with moder…

Interventions

Drug
TVB-3567
Orally administered capsule
Drug
Placebo
Orally administered capsule

Locations (2)

Celerion, Inc.
Tempe, Arizona
Nucleus Network
Melbourne, Victoria