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The Tolerability, Safety, and PK Characteristics of SIM1910-09 in Healthy Chinese Volunteers

Acute Ischemic Stroke Clinical Trial

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 Single/Multiple Dosing in Healthy Chinese Volunteers

Clinical Trial 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 single/multiple dosing in healthy Chinese adult volunteers.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05200728
Study type Interventional
Source Jiangsu Simcere Pharmaceutical Co., Ltd.
Contact Ru Lin
Phone 86-15521381683
Email [email protected]
Status Recruiting
Phase Phase 1
Start date December 2, 2021
Completion date December 31, 2022
View Details
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