NCT05332730

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

A Randomized, Double-blind, Single-dose, Parallel Three-arm Comparative Study on Pharmacokinetics and Safety of BAT2506 Injection Versus the EU-licensed and US-licensed Simponi® in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 375 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. The study planes to enroll 375 healthy male subjects who will be randomly assigned to the BAT2506 Injection group, Simponi® (EU-licensed) or Simponi® (US-licensed) groups in a 1:1:1 ratio to receive a single subcutaneous injection of 50 mg BAT2506 Injection or Simponi® (EU-licensed or US-licensed).

Conditions

• Psoriatic Arthritis

Interventions

Type	Name	Description
DRUG	BAT2506 injection	50 mg, subcutaneous administration
DRUG	Simponi® (EU commercially available product)	50 mg, subcutaneous administration
DRUG	Simponi® (US commercially available product)	50 mg, subcutaneous administration

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-27
• Completion: 2023-07-10
• First posted: 2022-04-18
• Last updated: 2023-08-28

Locations

1 site across 1 country: China