NCT04371185

Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects

A Randomized, Double-blinded, Single-dose, 3-arms Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Bio-Thera Solutions · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).

Detailed description

The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Ustekinumab, thus to evaluate the similarity of the pharmacokinetics of the three study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	BAT2206	45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
DRUG	Stelara(US-licensed)	45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
DRUG	Stelara(EU-licensed)	45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Timeline

• Start date: 2020-08-08
• Primary completion: 2021-04-19
• Completion: 2021-04-19
• First posted: 2020-05-01
• Last updated: 2021-09-13

Locations

1 site across 1 country: China