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

Samsung Bioepis Co., Ltd.1 site in 1 country201 target enrollmentFebruary 4, 2021

ConditionsHealthy

InterventionsUstekinumab

DrugsUstekinumab

Overview

Phase: Phase 1
Intervention: Ustekinumab
Conditions: Healthy
Sponsor: Samsung Bioepis Co., Ltd.
Enrollment: 201
Locations: 1
Primary Endpoint: AUCinf
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 4, 2021

End Date

April 1, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Bioepis Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male or female, aged 18-55 years (inclusive) on the day of signing the informed consent.
•Have a body weight between 60.0-90.0 kg (inclusive) and a body mass index (BMI) between 19.0-29.9 kg/m2 (inclusive) at Screening and Day -
•Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -
•Have vital sign results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -
•Have physical examination results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -
•Female subjects who are not pregnant or nursing at Screening and Day -1, and subjects who are not planning to become pregnant during study period and until 15 weeks after the IP administration.
•Female subjects of non-childbearing potential, defined as one of the following:
•At least 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., appropriate age) and follicle-stimulating hormone (FSH) in the range for menopausal female confirmed by blood test according to current local standards at Screening
•Those with history of hysterectomy or surgical removal of both ovaries. Documentation of surgical procedure performed at least 90 days prior to Screening or documentation of physical examination is required for confirmation of surgical sterilisation OR Female subjects of childbearing potential or male subjects with their (respectively male or childbearing female) partners who agree to use at least two forms of appropriate contraception method (e.g., established use of oral, injected, intravaginal, transdermal, or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine hormone-releasing system, physical barrier \[Note: Female condom and male condom should not be used together\]) from Screening until 15 weeks after the IP administration. Vasectomy alone will be allowed for male subjects and female subjects of childbearing potential with a sole vasectomised male partner. Vasectomised subjects or partners should be medically confirmed for sterilisation. True abstinence alone will be allowed if this is in line with the preferred and usual lifestyle of the subject, or for subjects who do not have a partner. Contraceptive methods do not apply for subjects whose partner is on the same gender.
•Willing and able to comply with the scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.

Exclusion Criteria

•Have a history and/or current presence of clinically significant atopic allergy, hypersensitivity, or allergic reactions (either spontaneous or following drug administration), also including known or suspected clinically relevant drug hypersensitivity to ustekinumab or to any of the excipients.
•Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, neurologic (including reversible posterior leukoencephalopathy syndrome), metabolic (including known diabetes mellitus), psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies.
•Have a history of significant respiratory disorder (including asthma, non-infectious pneumonia).
•Have a history of malignancy (including lymphoma, leukaemia, and skin cancer).
•Have either active or latent tuberculosis (TB) as indicated by a positive test result for Mycobacterium tuberculosis at Screening or who have a history of TB.
•Have a history of serious infection (associated with hospitalisation and/or which required IV antibiotics) within 180 days prior to Randomisation.
•Have a history of invasive systemic fungal infections (e.g., histoplasmosis) or other opportunistic infections judged relevant by the Investigator.
•Have a clinically significant active infection (bacterial, viral, or fungal) within 28 days prior to Randomisation.
•Have any systemic or local infection, a known risk for developing sepsis and/or a known active inflammatory process at Screening or Day -
•Have previously been exposed to ustekinumab (Stelara® and its biosimilar).