40
Participants
Start Date
June 5, 2019
Primary Completion Date
August 16, 2019
Study Completion Date
August 16, 2019
Group 1: Compound Edaravone/Placebo Injection
Compound Edaravone 30mg-600mg (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) / placebo single intravenous infusion for 30min
Group 2: Compound Edaravone/Placebo Injection
Compound Edaravone 60mg-1200mg (containing edaravone 60 mg and 2-aminoethanesulfonic acid 1200 mg) / placebo single intravenous infusion for 30min
Group 3: Compound Edaravone/Placebo Injection
Compound Edaravone 90mg-1800mg (containing edaravone 90 mg and 2-aminoethanesulfonic acid 1800 mg) / placebo single intravenous infusion for 30min
Group 4: Compound Edaravone/Placebo Injection
Compound Edaravone 120mg-2400mg (containing edaravone 120 mg and 2-aminoethanesulfonic acid 2400 mg) / placebo single intravenous infusion for 30min
Group 5: Compound Edaravone/Placebo Injection
Maximum tolerated dose of drug / placebo for a single intravenous infusion for 30 minutes three times a day at an interval of 8 h until the last dose on the morning of Day 3, after which the sequential test drug 30 mg-600 mg / placebo will be administered daily from Day 3 night Intravenous infusion, 30 minutes at 12-hour intervals until morning on Day 7
Beijing Tiantan Hospital, Capital Medical University, Beijing
Nanjing Yoko Biomedical Co., Ltd.
INDUSTRY