68
Participants
Start Date
December 6, 2021
Primary Completion Date
March 23, 2023
Study Completion Date
March 23, 2023
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."
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."
Beijing Tiantan Hospital, Capital Medical University, Beijing
Lead Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
INDUSTRY