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A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

Healthy Men Clinical Trial

Official title:
A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

Clinical Trial Summary

This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.

Clinical Trial Description

A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously. A 14-day screening period is set in this study. Subjects will be admitted one day prior to administration (Day -1) and can be discharged only upon completion of relevant observations and evaluations after administration on Day 5. After discharge, subjects need to return to the hospital for 10 follow-ups as required in the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05968508
Study type Interventional
Source Bio-Thera Solutions
Contact
Status Active, not recruiting
Phase Phase 1
Start date August 29, 2023
Completion date April 2024
View Details
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