A Phase 1 interventional study of BAT2022 in SARS-CoV-2 Infection, sponsored by Bio-Thera Solutions. Completed at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-11-15.
Sponsored by Bio-Thera Solutions · Phase 1, Interventional, and Treatment
To evaluate the safety and tolerability of BAT2022 in healthy subjects.
This is a single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the pharmacokinetics, safety, tolerability, immunogenicity and pharmacodynamics of BAT2022 for Injection in healthy subjects.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 32 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Bio-Thera Solutions is the lead sponsor of 54 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
: Inclusion Criteria:
Exclusion Criteria:
Drug:BAT2022 for Intravenous fluids 100mg
Drug: BAT2022
Drug:BAT2022 for Intravenous fluids 300mg
Drug: BAT2022
Drug:BAT2022 for Intravenous fluids 1000mg
Drug: BAT2022
Drug:BAT2022 for Intravenous fluids 1500mg
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.
Also known as: BAT2022 for Injection (bispecific neutralizing antibody targeting the receptor binding domain (RBD) of spike of SARS-CoV-2)
Dose limiting toxicity (DLT)
Grade ≥3 AEs in this criteria are defined as dose-limiting toxicity (DLT).
Time frame: DLT observation period is 7 days postdose.
Maximum tolerated dose (MTD)
it is determined that ≥ 50% of subjects have experienced a DLT as defined in this protocol
Time frame: DLT observation period is 7 days postdose.
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Bio-Thera Solutions