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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
Jiangsu Hansoh Pharmaceutical Co., Ltd.·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Schizophrenia
Drug/Device/Intervention
HS-10509
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Location
Changchun, China
Timeline & enrollment
Phase
Phase 1
Start date
Mar 01, 2024
End date
Oct 01, 2024
Enrollment
80 participants
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
SchizophreniaSimple schizophreniaSchizophrenia, unspecifiedOther schizophreniaParanoid schizophrenia
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06301074
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.