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Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT03254810
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Synermore Biologics Co., Ltd.

Brief Summary:
This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American and European sources. The study is open to healthy individuals on no medications that might confound the results of this safety study.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Biological: SYN060 Biological: Adalimumab North American source Biological: Adalimumab European source Phase 1

Detailed Description:

This is a single site, parallel randomized, double blinded comparison of the safety, pharmacokinetics, and immunogenicity of a single 0.57 mg/kg dose of SYN060 to a single 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American and European sources. The study is open to healthy individuals on no medications that might confound the results of this safety study.

A total of 90 subjects will be randomized in a 1:1:1 ratio to from a centrally generated randomization schedule to SYN060 or adalimumab of American or European sources resulting in 30 subjects in each group.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Randomized Blinded Single Dose Comparison of the Safety and Pharmacokinetics of SYN060 Compared to Adalimumab (Humira®) From North American and European Sources in Healthy Adult Subjects
Actual Study Start Date : September 26, 2017
Actual Primary Completion Date : July 17, 2018
Actual Study Completion Date : July 17, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: SYN060
a single 0.57 mg/kg dose of SYN060
Biological: SYN060
a single subcutaneous 0.57 mg/kg dose of SYN060

Active Comparator: Adalimumab North American source
a single 0.57 mg/kg dose of adalimumab from North American source
Biological: Adalimumab North American source
a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American source

Active Comparator: Adalimumab European source
a single 0.57 mg/kg dose of adalimumab from European source
Biological: Adalimumab European source
a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from European source




Primary Outcome Measures :
  1. AUC0-last (area under the concentration-time curve from time zero to the last non-zero concentration) and AUC0-inf (area under the concentration-time curve from time zero to infinity) [ Time Frame: 85 days ]
    AUC0-last and AUC0-inf will be estimated using non-compartmental analysis fpr SYN060 to adalimumab (Humira®) from North American and European sources.

  2. Cmax (maximum observed concentration) [ Time Frame: 85 days ]
    Cmax will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources

  3. Residual area (%AUCextrap) [percent extrapolated area under the curve to infinity calculated as 100*(1- AUC0-last / AUC0-inf)] [ Time Frame: 85 days ]
    Residual area (%AUCextrap) will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources

  4. Tmax (time of observed Cmax) [ Time Frame: 85 days ]
    Tmax will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources

  5. t½ (elimination half-life) [ Time Frame: 85 days ]
    t½ will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources

  6. λz (elimination rate constant) [ Time Frame: 85 days ]
    λz will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources

  7. CL/F (apparent body clearance, calculated as Dose/AUC0-inf) [ Time Frame: 85 days ]
    CL/F will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources

  8. Vz/F [apparent volume of distribution, calculated as Dose/ (λz x AUC0-inf)] [ Time Frame: 85 days ]
    Vz/F will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources


Secondary Outcome Measures :
  1. Adverse event incidence of SYN060 compared to adalimumab (Humira®) from North American and European sources [ Time Frame: 85 days ]
    Safety monitoring will include vital signs (blood pressure, temperature, pulse, oximetry and respiration rates), physical examination, electrocardiogram (ECG) and clinical laboratory tests (serum chemistry, hematology, troponins, creatinine phosphokinase [CPK], human anti-SYN060 antibodies, human anti-adalimumab antibodies and urinalysis). Adverse events will be recorded throughout the study and will be coded using the most current version of MedDRA (Medical Dictionary for Regulatory Activities) at the time of study commencement.

  2. anti-SYN060 antibodies [ Time Frame: 85 days ]
    The development of anti-SYN060 antibodieswill be determined on Study Days 0, and 7 through 85, or the last blood specimen available for subjects who leave the study prior to Day 85. The development of anti-SYN060 antibodies will be analyzed as a continuous measure across categorical groups and compared to anti-adalimumab antibodies with descriptive statistics.

  3. anti-adalimumab antibodies [ Time Frame: 85 days ]
    The development of anti-adalimumab antibodies will be determined on Study Days 0, and 7 through 85, or the last blood specimen available for subjects who leave the study prior to Day 85. The development of anti-adalimumab antibodies will be analyzed as a continuous measure across categorical groups and compared to anti-SYN060 antibodies with descriptive statistics.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subjects between 18 and 50 years of age, inclusive
  2. Body mass index between 18 and 30 kg/m², inclusive
  3. Female subjects physically capable of pregnancy (i.e., not sterilized and still menstruating or within 1 year of the last menses if menopausal) must:

    1. Agree to avoid pregnancy from the Study Day screening visit through six months after receipt of Study Drug.
    2. If in a sexual relationship with a man, use an acceptable method of avoiding pregnancy during this period, still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring or intrauterine device (IUD).
  4. Women of childbearing potential must have a negative serum pregnancy test within 24 hours preceding receipt of the dose.
  5. Can understand and sign the informed consent document, can communicate with the investigator and provide updated contact information as needed for the duration of the study, has no current plans to move from the study area for the duration of the study, and can understand and comply with the requirements of the protocol.

Exclusion Criteria:

  1. Acute illness on Study Day 1
  2. Oral temperature ≥37.5°C on Study Day 1
  3. Inability to discontinue daily medications other than oral contraceptives or other hormonal therapy.
  4. Receipt of an immunoglobulin or blood product within 90 days prior to Study Day 1
  5. Any receipt of adalimumab, or other licensed monoclonal antibody
  6. Any receipt of another investigational product within 4 weeks or 4 half-lives whichever is longer prior to Study Day 1
  7. Abnormal laboratory values per local laboratory parameters from blood collected at screening prior to Study Day 1 randomization as follows:

    • Severe anemia, defined as haemoglobin <100 g/L or hematocrit <0.3 L/L
    • absolute neutrophil count, below lower limit of normal (LLN)
    • white blood cell count above upper limit of normal (ULN) or below LLN (i.e., must be within normal limits)
    • ALT, AST, alkaline phosphatase (ALP) above ULN with exception that a one of the three values may be permitted up to 10% above ULN.
    • Creatinine above upper limit of normal ,
    • INR, or activated partial thromboplastin time (APTT) above ULN
  8. Abnormal screening urinalysis result that is, per the investigator, clinically significant, or a screening urine dipstick result of ≥2+ protein
  9. Positive screening urine test for illicit drugs (amphetamines, methamphetamines, barbiturates, benzodiazepine, cocaine, opiates, PCP, MDMA, methadone)
  10. History of systemic allergic reactions, to more than one medication.
  11. History or evidence of malignancy.
  12. Receipt of immunosuppressive medications other than inhaled or topical immunosuppressant drugs such as corticosteroids within 45 days prior to Study Day 1
  13. Hepatitis B surface antigen positive, HIV positive, hepatitis C antibody positive
  14. Uncontrolled Type 2 Diabetes or Type I diabetes
  15. History systemic fungal infection.
  16. Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
  17. Previous medical history that may compromise the safety of the subject in the study, including but not limited to: severe impairment of pulmonary function or other pulmonary disease; chronic illness with signs of cardiac or renal failure; suspected progressive neurological disease or poorly controlled epilepsy
  18. History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety of the Study Drug
  19. History or evidence of tuberculosis infection
  20. Positive Quantiferon test
  21. Chest X ray with evidence of malignancy or chronic infection (such as tuberculosis or other)
  22. Any current medical, psychiatric, occupational, or substance abuse problem such as alcoholism that, in the opinion of the investigator, will make it unlikely that the subject will comply with the protocol.
  23. Elective surgery that would interfere with participation.
  24. Live virus vaccination within 60 days and during the study.
  25. Blood donation less than 30 days prior to Study Day 1.

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): NCT03254810


Locations
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Australia, Victoria
Nucleus Network
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Synermore Biologics Co., Ltd.
Investigators
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Principal Investigator: Niquita Tugiono, MD Nucleus Network, Center for Clinical Studies Study Site

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Responsible Party: Synermore Biologics Co., Ltd.
ClinicalTrials.gov Identifier: NCT03254810     History of Changes
Other Study ID Numbers: SYN060-001
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents