Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

November 7, 2022

Study Completion Date

November 7, 2022

Conditions
SARS-CoV-2 Infection
Interventions
DRUG

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.

Trial Locations (1)

430030

Union Hospital Tong Ji Medical College University of Science and Technology, Wuhan

Sponsors
All Listed Sponsors
lead

Bio-Thera Solutions

INDUSTRY