45
Participants
Start Date
April 11, 2022
Primary Completion Date
January 9, 2023
Study Completion Date
January 9, 2023
SIBP-R002
SIBP-R002: injection; strength: 1, 2, 4, 8 or 12 mg; dose escalation and the first group is 1mg (intravenous infusion, 5 groups, the first group consisted of four people, and the other groups consisted of eight).
Dexamethasone or Methyl prednisolone
Intravenous infusion, 5mg or 1\~2mg/kg. These were administered within 30 minutes prior to infusion of the experimental drug.
Diphenhydramine
10mg, intramuscular injection.These were administered within 30 minutes prior to infusion of the experimental drug.
Placebo
The same volume of placebo as SIBP-R002: injection; strength: the same volume of placebo as SIBP-R002 of 1, 2, 4, 8 or 12 mg (intravenous infusion, 5 groups, the first group consisted of one people, and the other groups consisted of two). The rule and dose of placebo were the same as SIBP-R002.
The first affiliated hospital of Bengbu medical college, Bengbu
The First Affiliated Hospital of Bengbu Medical University
OTHER
Shanghai Institute Of Biological Products
INDUSTRY