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Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03722329
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE October 26, 2018
Last Update Posted Date January 9, 2020
Actual Study Start Date  ICMJE November 13, 2018
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
AUCinf [ Time Frame: Day 1 to Day 64 ]
Area under the concentration-time curve from time zero to infinity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • AUClast [ Time Frame: Day 1 to Day 64 ]
    Area under the concentration-time curve from time zero to the last quantifiable concentration
  • Cmax [ Time Frame: Day 1 to Day 64 ]
    Maximum observed serum concentration
  • Tmax [ Time Frame: Day 1 to Day 64 ]
    Time to reach Cmax
  • Vz [ Time Frame: Day 1 to Day 64 ]
    Volume of distribution during terminal phase
  • λz [ Time Frame: Day 1 to Day 64 ]
    Terminal rate constant
  • T1/2 [ Time Frame: Day 1 to Day 64 ]
    Terminal half-life
  • Clearance [ Time Frame: Day 1 to Day 64 ]
    Total body clearance
  • %AUCextrap [ Time Frame: Day 1 to Day 64 ]
    Percentage of AUCinf due to extrapolation from time of last measurable concentration (Tlast) to infinity
  • Incidence of Treatment-Emergent Adverse Events [ Time Frame: Day 1 to Day 64 ]
    Experience at least 1 treatment-emergent adverse event
  • Incidence of Serious Adverse Events [ Time Frame: Day 1 to Day 64 ]
    Experience at least 1 serious adverse event
  • Incidence of ADA [ Time Frame: Day 1 to Day 64 ]
    Incidence of anti-drug antibodies
  • Incidence NAb [ Time Frame: Day 1 to Day 64 ]
    Incidence neutralising antibodies
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic, Safety, Tolerability, Immunogenicity, and Pharmacodynamic Study of SB12 in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE Drug: Eculizumab
Eculizumab Injection. 300 mg, single dose
Study Arms  ICMJE
  • Experimental: SB12
    SB12 (proposed eculizumab biosimilar)
    Intervention: Drug: Eculizumab
  • Active Comparator: EU Soliris
    EU sourced Soliris (eculizumab)
    Intervention: Drug: Eculizumab
  • Active Comparator: US Soliris
    US sourced Soliris (eculizumab)
    Intervention: Drug: Eculizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2018)
240
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 8, 2019
Actual Primary Completion Date March 29, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03722329
Other Study ID Numbers  ICMJE SB12-1001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Samsung Bioepis Co., Ltd.
Study Sponsor  ICMJE Samsung Bioepis Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rainard Fuhr, MD PAREXEL International GmbH, Early Phase Clinical Unit - Berlin
PRS Account Samsung Bioepis Co., Ltd.
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP