Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05964790
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-28
First Post:
2023-07-10
Brief Title:
Safety Tolerability Pharmacokinetics and Efficacy Study of HS-10380 in Patients With Schizophrenia
Sponsor:
Jiangsu Hansoh Pharmaceutical Co Ltd
Organization:
Jiangsu Hansoh Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase ⅠbⅡ Multicenter Randomized Placebo-Controlled Double-Blind Study to Investigate the Safety Tolerability Pharmacokinetics and Efficacy of HS-10380 in Chinese Adults With Schizophrenia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the safety tolerability pharmacokinetics and efficacy of HS-10380 relative to placebo for the treatment of participants with schizophrenia
Detailed Description:
The trial consists of two parts dose escalation cohorts and expansion cohorts The primary aim of the dose escalation cohorts is to evaluate the safety and tolerability of HS-10380 in participants with schizophrenia and the primary aim of expansion cohorts is to evaluate efficacy of HS-10380 in participants with schizophrenia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None