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Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03722329
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Brief Summary:
This study is to evaluate PK, safety, tolerability, immunogenicity, and PD profiles of SB12, EU sourced Soliris, and US sourced Soliris in healthy subjects.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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, Safety, Tolerability, Immunogenicity, and Pharmacodynamics of Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®) in Healthy Subjects
Actual Study Start Date : November 13, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab

Arm Intervention/treatment
Experimental: SB12
SB12 (proposed eculizumab biosimilar)
Drug: Eculizumab
Eculizumab Injection. 300 mg, single dose

Active Comparator: EU Soliris
EU sourced Soliris (eculizumab)
Drug: Eculizumab
Eculizumab Injection. 300 mg, single dose

Active Comparator: US Soliris
US sourced Soliris (eculizumab)
Drug: Eculizumab
Eculizumab Injection. 300 mg, single dose




Primary Outcome Measures :
  1. AUCinf [ Time Frame: Day 1 to Day 64 ]
    Area under the concentration-time curve from time zero to infinity


Secondary Outcome Measures :
  1. AUClast [ Time Frame: Day 1 to Day 64 ]
    Area under the concentration-time curve from time zero to the last quantifiable concentration

  2. Cmax [ Time Frame: Day 1 to Day 64 ]
    Maximum observed serum concentration

  3. Tmax [ Time Frame: Day 1 to Day 64 ]
    Time to reach Cmax

  4. Vz [ Time Frame: Day 1 to Day 64 ]
    Volume of distribution during terminal phase

  5. λz [ Time Frame: Day 1 to Day 64 ]
    Terminal rate constant

  6. T1/2 [ Time Frame: Day 1 to Day 64 ]
    Terminal half-life

  7. Clearance [ Time Frame: Day 1 to Day 64 ]
    Total body clearance

  8. %AUCextrap [ Time Frame: Day 1 to Day 64 ]
    Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity

  9. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Day 1 to Day 64 ]
    Experience at least 1 treatment-emergent adverse event

  10. Incidence of Serious Adverse Events [ Time Frame: Day 1 to Day 64 ]
    Experience at least 1 serious adverse event

  11. Incidence of ADA [ Time Frame: Day 1 to Day 64 ]
    Incidence of anti-drug antibodies

  12. Incidence NAb [ Time Frame: Day 1 to Day 64 ]
    Incidence neutralising antibodies



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.


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

Inclusion Criteria:

  • Written informed consent
  • Have a body weight between 70-95 kg and a body mass index between 20.0-29.9 kg/m²
  • Have systolic blood pressure (SBP) ≤ 140 and ≥ 90 mmHg, diastolic blood pressure (DBP) ≤ 95 and ≥ 45 mmHg, and pulse rate ≥ 40 and ≤ 100 beats per minute or assessed as not clinically significant
  • Have physical examination and 12-lead ECG results without clinically significant finding at Screening and Day -1 visits
  • Non-smoker or smoker whose daily smoking does not exceed 10 cigarettes, 3 cigars, or 3 pipes for at least 30 days prior to Screening visit. Subjects should agree to abstain from smoking while resident at the clinical study site.
  • Willing to receive vaccination against N. meningitidis at least 14 days prior to IP administration
  • Male subjects 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 unless their partner is infertile from the time of IP administration until 5 months after IP administration
  • Must be willing and able to comply with scheduled visits, treatment plan, clinical laboratory tests, and other study procedures including lifestyle considerations
  • Have competence in speaking, writing and comprehending the local language where the study is conducted

Exclusion Criteria:

  • Have a history/presence of clinically significant atopic allergy, allergic/hypersensitive reactions, or known or suspected clinically relevant drug hypersensitivity to eculizumab or its excipients
  • Contraindication for IP or non-IP to be used in the study
  • History of N. meningitidis infection
  • Known or suspected hereditary or acquired complement deficiency
  • Clinically significant active infection within 28 days before IP administration
  • Any systemic or local infection, a known risk for developing sepsis and/or known active inflammatory condition
  • Have previously been exposed to eculizumab (Soliris and its biosimilar)
  • Previous treatment with a monoclonal antibody or fusion protein within 9 months prior to IP administration and/or have an evidence 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 IP administration
  • Any of the following abnormal laboratory values at Screening and Day -1 visits:

    1. Serum alanine transaminase and/or aspartate transaminase ≥ 1.5 × ULN
    2. Serum C-reactive protein ≥ 10 mg/L
    3. Serum creatinine > 1.5 × ULN
    4. Whole blood cell count < 3000/mm3, absolute lymphocyte count < 800/mm3, and/or absolute neutrophil count ≤ 1500/mm3
    5. Any other laboratory abnormalities assessed as clinically significant by the Investigator
  • Positive test result for hepatitis B surface antigen and/or hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus at Screening
  • Surgery within 90 days prior to IP administration, and/or operation during study period
  • Average intake of alcoholic beverages of more than 21 units/week for males and 14 units/week for females
  • Drug abuse or a positive urinary drug screening result
  • Have any prescription medicine or over-the-counter medicines (except paracetamol) that might have an effect on the objectives of the study, within 14 days prior to IP administration
  • Donated >100 mL blood or plasma within 28 days prior to IP administration
  • Subject directly involved in the conduct of the clinical study
  • Vulnerable subjects
  • Pregnant or nursing (lactating) women

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): NCT03722329


Contacts
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Contact: Samsung Bioepis SBTrialRegistry +82 31 8061 4534 sbregistry@samsung.com

Locations
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Germany
PAREXEL International GmbH, Early Phase Clinical Unit - Berlin Recruiting
Berlin, Germany, 14050
Contact: Rainard Fuhr, MD         
Principal Investigator: Rainard Fuhr, MD         
Sub-Investigator: Rüdiger Kornberger, MD         
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
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Principal Investigator: Rainard Fuhr, MD PAREXEL International GmbH, Early Phase Clinical Unit - Berlin

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Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT03722329     History of Changes
Other Study ID Numbers: SB12-1001
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes