NCT05518695

Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects

A Randomized, Double-Blind, Phase I Clinical Study to Evaluate the Pharmacokinetics of BAT2022 in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of BAT2022 in healthy subjects.

Detailed description

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.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-09
• Primary completion: 2022-11-07
• Completion: 2022-11-07
• First posted: 2022-08-29
• Last updated: 2022-11-15

Locations

1 site across 1 country: China