NCT06301074

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

A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Phase Ⅰ Study to Evaluate the Tolerability and Pharmacokinetics of HS-10509 in Chinese Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The study is to evaluate the safety, tolerability, and PK characteristics following single administration of HS-10509 in healthy adults, and multiple administrations of HS-10509 in patients with schizophrenia. Participants will have HS-10509 tablets or placebo once in the single ascending dose (SAD) part or once daily for 28 days in the multiple ascending dose (MAD) part.

Detailed description

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	HS-10509	In SAD, participants will be assigned to receive either HS-10509 or a matching placebo for a single administration. There are 5 predefined dose cohorts (each cohort including 8 for HS-10509 and 2 for placebo), initially starting at 10 mg for cohort 1. In MAD, participants will assigned to receive HS-10509 or a matching placebo once daily for 28 days. There will be 3 dose cohorts (each cohort including 8 for HS-10509 and 2 for placebo), and the dose for each cohort is to be determined.
DRUG	Placebo	In SAD, participants will be assigned to receive either HS-10509 or a matching placebo for a single administration. There are 5 predefined dose cohorts (each cohort including 8 for HS-10509 and 2 for placebo), initially starting at 10 mg for cohort 1. In MAD, participants will assigned to receive HS-10509 or a matching placebo once daily for 28 days. There will be 3 dose cohorts (each cohort including 8 for HS-10509 and 2 for placebo), and the dose for each cohort is to be determined.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-05-01
• Completion: 2024-10-01
• First posted: 2024-03-08
• Last updated: 2024-03-08

Locations

1 site across 1 country: China