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 | Completed Phase 1

• 1 other identifier: SB17-1001
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• AUCinf

  Area under the concentration-time curve from time zero to infinity

  Day 1 to Day 99

• Cmax

  Maximum serum concentration

  Day 1 to Day 99

Secondary Outcomes (3)

• Incidence of treatment-emergent adverse events (TEAEs)

  Day 1 to Day 99

• Incidence of serious adverse events (SAEs)

  Day 1 to Day 99

• Incidence of anti-drug antibodies (ADAs)

  Day 1 to Day 99

Study Arms (3)

SB17

EXPERIMENTAL

SB17 (proposed ustekinumab biosimilar)

Drug: Ustekinumab

EU Stelara

ACTIVE COMPARATOR

EU sourced Stelara (ustekinumab)

Drug: Ustekinumab

US Stelara

ACTIVE COMPARATOR

US sourced Stelara (ustekinumab)

Drug: Ustekinumab

Interventions

Ustekinumab DRUG

45 mg, single-dose

EU Stelara; SB17; US Stelara

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 -1.
• Have 12-lead electrocardiogram (ECG) results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
• Have vital sign results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
• Have physical examination results without clinically significant abnormal findings confirmed by the Investigator at Screening and Day -1.
• 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.
• Provision of signed and dated written informed consent, which must be obtained prior to any study-related procedures being performed.
• Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.

You may not qualify if:

• 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 -1.
• Have previously been exposed to ustekinumab (Stelara® and its biosimilar).
• Have previously been exposed to a monoclonal antibody or fusion protein within 270 days (other than ustekinumab) prior to Randomisation and/or there is confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
• Have previously been exposed to an immunosuppressive agent or biological agent (any other than a monoclonal antibody or fusion protein) within 120 days prior to Randomisation.
• Have received Bacillus of Calmette and Guerin (BCG) vaccine within 12 months prior to Randomisation or will require BCG vaccine within 12 months after the IP administration.
• Have received live vaccine(s) (other than the BCG vaccine) within 30 days prior to Randomisation or will require live vaccine(s) within 15 weeks after the IP administration.
• Have a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (1)

Biotrial Rennes

Rennes, France

Location

MeSH Terms

Interventions

Ustekinumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hakim Charfi, MD

  Biotrial Rennes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 26, 2021
• Study Start: February 4, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-04

Locations

FR (1)