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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 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2022-04-05

No results posted yet for this study

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

Conditions

  • Healthy

Interventions

DRUG

Ustekinumab

45 mg, single-dose

Sponsors & Collaborators

  • Samsung Bioepis Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hakim Charfi, MD · Biotrial Rennes

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04772274 on ClinicalTrials.gov