32
Participants
Start Date
June 9, 2022
Primary Completion Date
November 7, 2022
Study Completion Date
November 7, 2022
BAT2022
Eight healthy subjects are planned to be enrolled in each group, 6 on the investigational product and 2 on placebo. Subjects will be randomized (3:1) to receive a single intravenous injection of BAT2022 for Injection or 5% glucose injection. Sentinel dosing will be performed for subjects in each group.Two subjects in each group who have received the first dose will be randomized (1:1) to either the test group or placebo group. After observation for 24 h and the drug is safe and well tolerated, the remaining subjects in this group will be randomized (5:1) to either the test group or placebo group.
Union Hospital Tong Ji Medical College University of Science and Technology, Wuhan
Lead Sponsor
Bio-Thera Solutions
INDUSTRY