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

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT04772274
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Feb 4, 2021
Status verified
Apr 2022
Primary completion
Apr 1, 2022
Completion
Apr 1, 2022

Study Design

Enrollment
201 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: SB17
    SB17 (proposed ustekinumab biosimilar)
  • Active Comparator: EU Stelara
    EU sourced Stelara (ustekinumab)
  • Active Comparator: US Stelara
    US sourced Stelara (ustekinumab)

Primary Outcome Measure

AUCinf [ Time Frame: Day 1 to Day 99 ]

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