NCT05968508

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Men

Interventions

Type	Name	Description
DRUG	BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)	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.

Timeline

• Start date: 2023-08-29
• Primary completion: 2024-10-08
• Completion: 2024-10-08
• First posted: 2023-08-01
• Last updated: 2025-05-29

Locations

1 site across 1 country: China