drugset / Trial / NCT05332730

A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®

NCT05332730

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects.

Timeline

Start
2022-08-01
Primary completion
2023-06-27
Completion
2023-07-10

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT2506 Unknown 50 mg Subcutaneous
Comparator Golimumab Monoclonal antibody 50 mg Subcutaneous

Indications