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
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.
⁃ Healthy Participants (Parts A, B and C)
• 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
⁃ 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:
• BMI ≥18.0 and ≤37.0 kg/m2.
• Must be diagnosed with moderate to severe acne vulgaris