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, 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
History or presence of clinically significant medical or psychiatric condition or disease
History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products.
Has a clinically significant ophthalmic examination finding
Female participant of childbearing potential