The Phase I Study of HS-10509 in Chinese Adult Subjects

This is a first-in-human, randomized, double-blinded, and placebo-controlled study. In the single-ascending dose (SAD) part, subjects will receive HS-10509 tablets or placebo once. There are 5 predefined dose cohorts of 10 subjects each (including 8 for HS-10509 and 2 for placebo). SAD part of the study will assess the safety, tolerability, and PK characteristics of single ascending doses of HS-10509 to determine the dose range that is safe and well tolerated in healthy subjects. In the multiple ascending dose (MAD) part, patients with schizophrenia will receive HS-10509 or placebo once daily for continously 28 days. There are 3 predefined dose cohorts with 10 subjects each (including eight for HS-10509 and 2 for placebo). MAD of the study will assess the safety, tolerability, PK and primary efficacy of multiple ascending doses of HS-10509 in subjects with schizophrenia.