drugset
drugset / Trial / NCT04772274

A Study to Compare SB17 (Proposed Ustekinumab Biosimilar) to European Union (EU) Sourced Stelara and United States of America (US) Sourced Stelara in Healthy Subjects

NCT04772274 ↗

Phase 1 Completed 201 enrolled Samsung Bioepis Co., Ltd.
RandomizedParallel-groupQuadruple-blindOther

Summary

This is a randomised, double-blind, three-arm, parallel group, single-dose study to evaluate the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 compared to EU sourced Stelara® and US sourced Stelara® in healthy subjects

Timeline

Start
2021-02-04
Primary completion
2022-04-01
Completion
2022-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ustekinumab Monoclonal antibody 45 mg Subcutaneous

Indications

No indication recorded.