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

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Ustekinumab (SB17, EU Sourced Stelara®, and US Sourced Stelara®) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Samsung Bioepis Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Ustekinumab	45 mg, single-dose

Timeline

• Start date: 2021-02-04
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-02-26
• Last updated: 2022-04-05

Locations

1 site across 1 country: France