Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 3 for:    SB16

Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04621318
Recruitment Status : Recruiting
First Posted : November 9, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Brief Summary:
This study is to compare PK, PD, safety, tolerability, and immunogenicity profiles of SB16, EU sourced Prolia, and US sourced Prolia in healthy male subjects.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia®, and US Sourced Prolia®) in Healthy Male Subjects
Actual Study Start Date : October 19, 2020
Estimated Primary Completion Date : August 3, 2021
Estimated Study Completion Date : August 3, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Denosumab

Arm Intervention/treatment
Experimental: SB16
SB16 (proposed denosumab biosimilar)
Drug: Denosumab
60 mg, single-dose

Active Comparator: EU Prolia
EU sourced Prolia (denosumab)
Drug: Denosumab
60 mg, single-dose

Active Comparator: US Prolia
US sourced Prolia (denosumab)
Drug: Denosumab
60 mg, single-dose




Primary Outcome Measures :
  1. AUCinf [ Time Frame: Day 1 to Day 197 ]
    Area under the concentration-time curve from time zero to infinity

  2. AUClast [ Time Frame: Day 1 to Day 197 ]
    Area under the concentration-time curve from time zero to the last quantifiable concentration

  3. Cmax [ Time Frame: Day 1 to Day 197 ]
    Maximum serum concentration


Secondary Outcome Measures :
  1. Tmax [ Time Frame: Day 1 to Day 197 ]
    Time to reach Cmax

  2. Vz/F [ Time Frame: Day 1 to Day 197 ]
    Apparent volume of distribution during the terminal phase

  3. λz [ Time Frame: Day 1 to Day 197 ]
    Terminal rate constant

  4. t1/2 [ Time Frame: Day 1 to Day 197 ]
    Terminal half-life

  5. CL/F [ Time Frame: Day 1 to Day 197 ]
    Apparent clearance

  6. %AUCextrap [ Time Frame: Day 1 to Day 197 ]
    Percentage of AUCinf due to extrapolation from Tlast to infinity

  7. AUEC for CTX percent inhibition [ Time Frame: Day 1 to Day 197 ]
    Area under the effect curve from time zero to Day 197 for serum CTX percent inhibition

  8. Incidence of TEAEs [ Time Frame: Day 1 to Day 197 ]
    Experience at least 1 TEAE

  9. Incidence of SAEs [ Time Frame: Day 1 to Day 197 ]
    Experience at least 1 SAE

  10. Incidence of ADAs [ Time Frame: Day 1 to Day 197 ]
    Incidence of ADAs to denosumab

  11. Incidence of NAbs [ Time Frame: Day 1 to Day 197 ]
    Incidence of NAbs to denosumab



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   28 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy male, aged 28-55 years (inclusive) on the day of signing the informed consent.
  2. Have a body weight between 60.0-90.0 kg (inclusive) and a BMI between 20.0-29.9 kg/m2 (inclusive).
  3. Have 12-lead ECG results without clinically significant abnormal findings confirmed by the Investigator.
  4. Have vital sign results without clinically significant abnormal findings confirmed by the Investigator.
  5. Have physical examination results without clinically significant abnormal findings confirmed by the Investigator.
  6. Male subjects who have not had 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 tubal ligation unless their partners are infertile (confirmed with written verifications) during the treatment period.
  7. Willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations.
  8. Able to provide written informed consent, which must be obtained prior to any study related procedures being performed.
  9. Have competence in speaking, writing, and comprehending the local language(s) where the study is conducted.

Exclusion Criteria:

  1. 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 denosumab or to any of the excipients.
  2. Have a history of and/or current clinically significant gastrointestinal, renal, hepatic, cardiovascular, haematological, pulmonary, neurologic, metabolic, psychiatric disorder, drug or alcohol abuse, or allergic disease excluding mild asymptomatic seasonal allergies.
  3. Have a history of bone disease or any medical condition that can affect bone metabolism (including osteoporosis, osteogenesis imperfecta, osteomalacia, hyperparathyroidism, hyperthyroidism, hypothyroidism, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Paget's disease of the bone, and malabsorption syndrome).
  4. Have a history of malignancy (including lymphoma, leukaemia, and skin cancer).
  5. Have ONJ or risk factors for ONJ such as invasive dental procedures or active periodontal disease within 180 days prior to Randomisation.
  6. Have bone fractures within 180 days prior to Randomisation.
  7. Have a history of serious infection (associated with hospitalisation and/or which required intravenous antibiotics) within 180 days prior to Randomisation.
  8. Have a clinically significant active infection (bacterial, viral, or fungal) including skin infections within 28 days prior to Randomisation.
  9. Have any systemic or local infection, a known risk for developing sepsis.
  10. Have known intolerance to calcium or vitamin D supplements.
  11. Have previously been exposed to denosumab (Prolia®/Xgeva®) and its biosimilar.
  12. Have previously been exposed to a monoclonal antibody or fusion protein within 270 days (other than denosumab) prior to Randomisation and/or there is confirmed evidence or clinical suspicion of immunogenicity from previous exposure to a monoclonal antibody or fusion protein.
  13. 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.
  14. Have received live vaccines(s) within 30 days prior to Randomisation or who will require live vaccine(s) during the study period.
  15. Have a personal or family history of prolonged QT interval syndrome or Torsade de Pointes, or family history of sudden death.
  16. Have any of the following abnormal laboratory test results:

    1. Albumin-adjusted serum calcium levels below the LLN or above the ULN.
    2. Serum creatinine levels above 1.5 × ULN.
    3. Any other laboratory abnormalities assessed as clinically significant by the Investigator.
  17. Have a positive test result for HBsAg, HCV antibody, or HIV 1or 2.
  18. Have a history of immunodeficiency.
  19. Have had surgery within 90 days prior to Randomisation, and/or plan to have an operation (including invasive dental procedure) during the study period.
  20. Have a history and/or current presence of an illness (including, but not limited to respiratory symptoms [e.g., difficulty breathing or persistent cough] or low-grade fever) within 14 days prior to Randomisation that is classified as clinically significant by the Investigator.
  21. Have smoked more than 10 cigarettes, 2 cigars, or 2 pipes per day within 90 days prior to Screening.
  22. Have regular consumption of alcoholic beverages that exceeds 14 units per week.
  23. Have a positive urinary drug screening result or alcohol breath test result at Screening or Day -1.
  24. Have taken 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 or 10 half-lives of the medication (whichever period is longer) prior to Randomisation. This includes medications such as, but not limited to: Bisphosphonates, parathyroid hormone, hormone replacement therapy, selective estrogen receptor modulators, calcitonin, calcitriol, glucocorticoids, fluoride, strontium, or anabolic steroids.
  25. Have donated > 100 mL blood or plasma within 28 days prior to Randomisation.
  26. Have 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 evaluation in this clinical study.
  27. Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
  28. 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.
  29. 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): NCT04621318


Contacts
Layout table for location contacts
Contact: Samsung Bioepis +81 31 8061 1096 sbregistry@samsung.com

Locations
Layout table for location information
France
Biotrial Rennes Recruiting
Rennes, France
Contact: Biotrial    +33 2 99 59 91 91      
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Hakim Charfi, MD Biotrial Rennes
Layout table for additonal information
Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT04621318    
Other Study ID Numbers: SB16-1001
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: November 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs