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