The primary objectives are to assess the safety, tolerability, and plasma PK of TLC-6740 in healthy subjects. The exploratory objective is to evaluate the PD of TLC-6740 in healthy subjects. This study is comprised of three parts: Part A (single-ascending dose), Part B (multiple-ascending dose), and optional Part C (adaptive single- and/or multiple-ascending dose). Up to 48, 50, and 50 healthy subjects will be recruited in Parts A, B, and C, respectively.
This phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of TLC-6740 after single- and multiple-ascending doses in healthy subjects.