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

PHASE1CompletedINTERVENTIONAL
Enrollment

68

Participants

Timeline

Start Date

December 6, 2021

Primary Completion Date

March 23, 2023

Study Completion Date

March 23, 2023

Conditions
Acute Ischemic StrokeCerebral Edema
Interventions
DRUG

SIM1910-09

"Part A-single ascending doses, SIM1910-09 will be administered by IV bolus infusion over a 30-min. The test doses are including of : 2mg/kg, 4mg/kg, 6mg/kg, 8mg/kg, which will be tested sequentially from low dose to high dose.~Part B-multiple ascending doses, SIM1910-09 will be administered as an initial bolus dose over 30-min, plus subsequent continuous infusion over 72 hours, the test doses are including of : 4mg/kg IV bolus infusion+0.03mg/kg/h continuous infusion;4mg/kg IV bolus infusion+0.1mg/kg/h continuous infusion;4mg/kg IV bolus infusion+0.3mg/kg/h continuous infusion;4mg/kg IV bolus infusion+0.6mg/kg/h continuous infusion,which will be tested sequentially from low dose to high dose."

DRUG

Placebo

"Part A-single ascending doses, placebo will be administered by IV bolus infusion over a 30-min. The test doses are including of : 2mg/kg, 4mg/kg, 6mg/kg, 8mg/kg, which will be tested sequentially from low dose to high dose.~Part B-multiple ascending doses, placebo will be administered as an initial bolus dose over 30-min, plus subsequent continuous infusion over 72 hours, the test doses are including of : 4mg/kg IV bolus infusion+0.03mg/kg/h continuous infusion;4mg/kg IV bolus infusion+0.1mg/kg/h continuous infusion;4mg/kg IV bolus infusion+0.3mg/kg/h continuous infusion;4mg/kg IV bolus infusion+0.6mg/kg/h continuous infusion,which will be tested sequentially from low dose to high dose."

Trial Locations (1)

100050

Beijing Tiantan Hospital, Capital Medical University, Beijing

All Listed Sponsors
lead

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY