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

  • STATUS
    Recruiting
  • participants needed
    201
  • sponsor
    Samsung Bioepis Co., Ltd.
Updated on 17 September 2021

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

Description

This study is a randomised, double-blind, three-arm, parallel group, single-dose study. A total of 201 healthy subjects aged 18-55 years will be randomised 1:1:1 to receive a single dose of either SB17, EU sourced Stelara, or US sourced Stelara. All investigational products (IPs) will be administered subcutaneously in the abdomen.

Details
Condition healthy
Treatment ustekinumab
Clinical Study IdentifierNCT04772274
SponsorSamsung Bioepis Co., Ltd.
Last Modified on17 September 2021

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