drugset / Trial / NCT05332730
A Study on Pharmacokinetics and Safety of BAT2506 Injection Versus Simponi®
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT2506 | Unknown | 50 mg | Subcutaneous |
| Comparator | Golimumab | Monoclonal antibody | 50 mg | Subcutaneous |