NCT05576454

Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects

A Randomized, Double-blinded, Single-dose, 3-arm Parallel Comparative Study on Pharmacokinetics and Safety of BAT2606 Injection Versus Mepolizumab Injection (EU-licensed Nucala® and US-licensed Nucala®) in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male subjects.

Detailed description

This is a single-center, randomized, double-blind, single-dose, parallel three arms comparative study of pharmacokinetics, safety and immunogenicity.

Conditions

• Severe Asthma

Interventions

Type	Name	Description
DRUG	Mepolizumab Injection (BAT2606 Injection)	In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection.
DRUG	Mepolizumab Injection (EU-licensed Nucala)	In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®).
DRUG	Mepolizumab Injection (US-licensed Nucala)	In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®).

Timeline

• Start date: 2022-09-20
• Primary completion: 2023-05-26
• Completion: 2023-06-19
• First posted: 2022-10-12
• Last updated: 2023-08-28

Locations

1 site across 1 country: China