The Phase I Study of HS-10509 in Chinese Adult Subjects - Trial NCT06301074
Access comprehensive clinical trial information for NCT06301074 through Pure Global AI's free database. This Phase 1 trial is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. and is currently Not yet recruiting. The study focuses on Schizophrenia. Target enrollment is 80 participants.
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Study Focus
Sponsor & Location
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Timeline & Enrollment
Phase 1
Mar 01, 2024
Oct 01, 2024
Primary Outcome
Incidence and severity of adverse events(AE) , serious AEs and AE leading to withdrawal from treatment.,Changes from baseline in lab tests,Changes from baseline in vital signs,Change from baseline in body weight,Change from baseline in Electrocardiogram (ECG),Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS),Change from baseline in Abnormal Involuntary Movement Scale (AIMS),Change from baseline in Barnes Akathisia Rating Scale (BARS),Change from baseline in Simpson-Angus Scale (SAS)
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06301074
Non-Device Trial