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

PHASE1CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

August 29, 2023

Primary Completion Date

October 8, 2024

Study Completion Date

October 8, 2024

Conditions
Healthy Men
Interventions
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.

Trial Locations (1)

Unknown

The Second Affiliated Hospital of Anhui Medical University, Hefei

Sponsors
All Listed Sponsors
lead

Bio-Thera Solutions

INDUSTRY