Ignite Creation Date:
2024-05-06 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05200728
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2021-11-18
Brief Title:
The Tolerability Safety and PK Characteristics of SIM1910-09 in Healthy Chinese Volunteers
Sponsor:
Jiangsu Simcere Pharmaceutical Co Ltd
Organization:
Jiangsu Simcere Pharmaceutical Co Ltd
Study Overview
Official Title:
A Single-center Randomized Double-blind Placebo-controlled Phase I Clinical Study to Evaluate the Tolerability Safety and PK Characteristics of SIM1910-09 After SingleMultiple Dosing in Healthy Chinese Volunteers
Status:
COMPLETED
Status Verified Date:
2023-11
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:
This is a single-center randomized double-blind placebo-controlled Phase I clinical study to evaluate the tolerability safety and pharmacokinetic characteristics of SIM1910-09 for injection after singlemultiple dosing in healthy Chinese adult volunteers
Detailed Description:
This is a double-blind randomized placebo-controlled sequential-group study with intravenously IV administered SIM1910-09 in healthy human subjects to assess the safety tolerability and pharmacokinetic parameters which include of single ascending dose part and multiple ascending doses part The primary objectives of this study are to assess the safety and tolerability of SIM1910-09 in healthy subjects Secondary objectives are to determine the pharmacokinetics of SIM1910-09 and SCR-6401 primary metabolite after administration of SIM1910-09 Exploratory objectives are to learn the inhibitory effect of SIM1910-09 and SCR-6401 on inflammation cytokine in ex vivo blood
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