drugset
drugset / Trial / NCT05200728

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

NCT05200728 ↗

Phase 1 Completed 68 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2021-12-06
Primary completion
2023-03-23
Completion
2023-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject SIM1910-09 Unknown 0.03 mg/kg Intravenous
Subject SIM1910-09 Unknown 0.1 mg/kg Intravenous
Subject SIM1910-09 Unknown 0.3 mg/kg Intravenous
Subject SIM1910-09 Unknown 0.6 mg/kg Intravenous
Subject SIM1910-09 Unknown 2 mg/kg Intravenous
Subject SIM1910-09 Unknown 4 mg/kg Intravenous
Subject SIM1910-09 Unknown 6 mg/kg Intravenous
Subject SIM1910-09 Unknown 8 mg/kg Intravenous

Indications

brain edema ischemic stroke