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Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT04514796
Recruitment Status : Completed
First Posted : August 17, 2020
Last Update Posted : May 26, 2021
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Brief Summary:
This study is to evaluate to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of SB5 in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: Adalimumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: A Randomised, Single-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects
Actual Study Start Date : August 13, 2020
Actual Primary Completion Date : May 15, 2021
Actual Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: 40 mg/0.4 mL of SB5
100 mg/mL of SB5
Drug: Adalimumab
SB5 (adalimumab), 40 mg, single-dose

Active Comparator: 40 mg/0.8 mL of SB5
50 mg/mL of SB5
Drug: Adalimumab
SB5 (adalimumab), 40 mg, single-dose




Primary Outcome Measures :
  1. AUCinf [ Time Frame: Day 1 to Day 57 ]
    Area under the concentration-time curve from time zero to infinity

  2. Cmax [ Time Frame: Day 1 to Day 57 ]
    Maximum serum concentration


Secondary Outcome Measures :
  1. AUClast [ Time Frame: Day 1 to Day 57 ]
    Area under the concentration-time curve from time zero to the last quantifiable concentration

  2. Tmax [ Time Frame: Day 1 to Day 57 ]
    Time to reach Cmax

  3. Vz/F [ Time Frame: Day 1 to Day 57 ]
    Apparent volume of distribution during the terminal phase

  4. λz [ Time Frame: Day 1 to Day 57 ]
    Terminal rate constant

  5. t1/2 [ Time Frame: Day 1 to Day 57 ]
    Terminal half-life

  6. CL/F [ Time Frame: Day 1 to Day 57 ]
    Apparent total body clearance

  7. %AUCextrap [ Time Frame: Day 1 to Day 57 ]
    Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity

  8. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Day 57 ]
    Experience at least 1 TEAE

  9. Incidence of serious adverse events (SAEs) [ Time Frame: Day 1 to Day 57 ]
    Experience at least 1 SAE

  10. Incidence of anti-drug antibodies (ADAs) [ Time Frame: Day 1 to Day 57 ]
    Incidence of ADAs to adalimumab

  11. Incidence of neutralising antibodies (NAbs) [ Time Frame: Day 1 to Day 57 ]
    Incidence of NAbs to adalimumab



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  1. Healthy male, aged 18-55 years (inclusive).
  2. A body weight between 65.0-90.0 kg (inclusive) and a body mass index between 20.0-29.9 kg/m2 (inclusive)
  3. 12-lead electrocardiogram results without clinically significant abnormal.
  4. Systolic blood pressure ≤ 140 and ≥ 90 mmHg, diastolic blood pressure ≤ 90 and ≥ 50 mmHg and pulse rate ≥ 45 and ≤ 90 beats per minute or assessed as not clinically significant.
  5. Physical examination results without clinically significant abnormal findings.
  6. Clinical laboratory results within the normal range or outside the normal range but assessed as not clinically significant.
  7. Male subjects who did not have surgical sterilisation must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception such as an intra-uterine device, oral contraceptive, injectable progesterone, sub-dermal implant, or a tubal ligation unless their partners are infertile from the time of the investigational product (IP) administration until 5 months after the IP administration.
  8. Willing and able to comply with study procedures including lifestyle consideration.
  9. Able to provide written informed consent prior to any study procedures.

Exclusion Criteria

  1. A history and/or current presence of clinically significant atopic, hypersensitivity or allergic, also including known or suspected clinically relevant drug hypersensitivity to adalimumab or to any of the excipients.
  2. A history of and/or current clinically significant gastrointestinal, renal, hepatic, haematological, pulmonary, neurologic, psychiatric, drug or alcohol abuse, or allergic disease excluding mild asymptotic seasonal allergies.
  3. Either active or latent tuberculosis (TB) or a history of TB.
  4. A history of invasive systemic fungal infections or other opportunistic infections.
  5. A history of any systemic or local infection, a known risk for developing sepsis and/or known active inflammatory process within 180 days prior to Randomisation.
  6. A sign of ongoing or chronic inflammation process defined as high blood concentration of C reactive protein (> 1.5 times the upper limit of normal).
  7. A history of serious infection (associated with hospitalisation and/or which required intravenous antibiotics) within 180 days prior to Randomisation.
  8. Previously been treated with adalimumab.
  9. Previously been exposed to a monoclonal antibody or fusion protein (other than adalimumab) within 180 days prior to Randomisation and/or there is a confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
  10. 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.
  11. Received live vaccine(s) within 30 days prior to Randomisation or who will require live vaccine(s) during the study period.
  12. A history of and/or current cardiac disease defined as one of the following:

    1. Personal or family history of prolonged QT interval syndrome or Torsade de Pointes.
    2. QT interval corrected by Fridericia's formulas > 450 msec or PR interval outside the range 120 to 220 msec.
    3. Signs and symptoms or any history suggestive for heart failure.
    4. Any other cardiac abnormalities or conditions assessed as clinically significant.
  13. Impaired liver, pancreas and biliary system as determined by one of the following:

    1. Serum alanine transaminase and/or aspartate transaminase ≥ 1.5 times the upper limit of normal.
    2. Gallbladder or bile duct disease classified as clinically significant.
    3. Acute or chronic pancreatitis.
    4. A positive hepatitis C virus antibody test or hepatitis B virus surface antigen test, or signs for active or chronic hepatitis B.
    5. Hepatic disease classified as clinically significant.
  14. A positive test result for human immunodeficiency virus, or have a history of immunodeficiency.
  15. A history of malignancy (including lymphoma and leukaemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localised carcinoma.
  16. Had surgery within 90 days prior to Randomisation, and/or who plan to have an operation during the study period.
  17. A history and/or current presence of an illness within 14 days prior to Randomisation that is classified as clinically significant.
  18. Have a history of and/or current Coronavirus Disease-19 (COVID-19) defined as one of the following:

    1. Positive test result for COVID-19 confirmed by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using real-time reverse transcriptase polymerase chain reaction (RT-PCR) at Day -1.
    2. Signs and symptoms consistent with COVID-19 30 days prior to Randomisation.
    3. Have had a positive test result for COVID-19 confirmed by SARS-CoV-2 detection using real-time RT-PCR.
    4. Had severe course of COVID-19.
  19. Smoked more than 10 cigarettes, 2 cigars or 2 pipes per day within 90 days prior to Screening.
  20. Regular consumption of alcoholic beverages that exceeds 14 units.
  21. A positive urinary drug screening result.
  22. Any prescription medicine or over-the-counter medicines (except paracetamol) that might have an effect on the objectives of the study in the opinion of the Investigator, within 30 days prior to Randomisation.
  23. Donated > 100 mL blood or plasma within 28 days prior to Randomisation.
  24. Participated in another study with an investigational drug within 60 days prior to Randomisation or are currently participating in or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
  25. Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
  26. Subject who is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the clinical study.
  27. Vulnerable subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514796


Locations
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Germany
Parexel International GmbH, Early Phase Clinical Unit Berlin
Berlin, Germany, 14050
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
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Principal Investigator: Thomas Köernicke, MD Parexel International GmbH, Early Phase Clinical Unit Berlin
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT04514796    
Other Study ID Numbers: SB5-1003
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents