Ignite Creation Date:
2024-05-06 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05196971
Status:
COMPLETED
Last Update Posted:
2023-03-09
First Post:
2022-01-09
Brief Title:
A Study To Evaluate The Safety Tolerability And Pharmacokinetics of HS-10345 In Treatment-Resistant Depression
Sponsor:
Jiangsu Hansoh Pharmaceutical Co Ltd
Organization:
Jiangsu Hansoh Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase IbRandomized Double-Blind Placebo-Controlled Study Evaluating The Safety Tolerability And Pharmacokinetics of HS-10345 In Chinese Adult Subjects With Treatment Resistant Depression
Status:
COMPLETED
Status Verified Date:
2023-02
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 purpose of this study is to assess the safety tolerability and pharmacokinetics of intranasal HS-10345 84mg compared with placebo in participants with treatment-resistant depression TRD
Detailed Description:
This will be a randomized double-blind placebo-controlled multicenter study Approximately 24 male and female adult participants diagnosed with TRD will participant in this study There will be 4 study phases a 4-week screening phase a 1-day baseline phase a double-blind treatment phase Day 1 to Day 15 and a 1-week post-treatment follow-up phase Firstly 12 patients will be assigned to intranasal placebo or HS-10345 of 84mg Extra 12 patients may be enrolled depending on the pharmacokinetics analysis of 84mg Safety assessments will be performed throughout the study The maximum study duration for a participant will be 7 weeks
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