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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03254810




Registration number
NCT03254810
Ethics application status
Date submitted
16/08/2017
Date registered
21/08/2017
Date last updated
19/11/2018

Titles & IDs
Public title
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
Scientific 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
Secondary ID [1] 0 0
SYN060-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arthritis, Rheumatoid 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - SYN060
Other interventions - Adalimumab North American source
Other interventions - Adalimumab European source

Experimental: SYN060 - a single 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

Active Comparator: Adalimumab European source - a single 0.57 mg/kg dose of adalimumab from European source


Other interventions: SYN060
a single subcutaneous 0.57 mg/kg dose of SYN060

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

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

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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) - AUC0-last and AUC0-inf will be estimated using non-compartmental analysis fpr SYN060 to adalimumab (Humira®) from North American and European sources.
Timepoint [1] 0 0
85 days
Primary outcome [2] 0 0
Cmax (maximum observed concentration) - Cmax will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Timepoint [2] 0 0
85 days
Primary outcome [3] 0 0
Residual area (%AUCextrap) [percent extrapolated area under the curve to infinity calculated as 100*(1- AUC0-last / AUC0-inf)] - Residual area (%AUCextrap) will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Timepoint [3] 0 0
85 days
Primary outcome [4] 0 0
Tmax (time of observed Cmax) - Tmax will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Timepoint [4] 0 0
85 days
Primary outcome [5] 0 0
t½ (elimination half-life) - t½ will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Timepoint [5] 0 0
85 days
Primary outcome [6] 0 0
?z (elimination rate constant) - ?z will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Timepoint [6] 0 0
85 days
Primary outcome [7] 0 0
CL/F (apparent body clearance, calculated as Dose/AUC0-inf) - CL/F will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Timepoint [7] 0 0
85 days
Primary outcome [8] 0 0
Vz/F [apparent volume of distribution, calculated as Dose/ (?z x AUC0-inf)] - Vz/F will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Timepoint [8] 0 0
85 days
Secondary outcome [1] 0 0
Adverse event incidence of SYN060 compared to adalimumab (Humira®) from North American and European sources - 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.
Timepoint [1] 0 0
85 days
Secondary outcome [2] 0 0
anti-SYN060 antibodies - 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.
Timepoint [2] 0 0
85 days
Secondary outcome [3] 0 0
anti-adalimumab antibodies - 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.
Timepoint [3] 0 0
85 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Synermore Biologics Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03254810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niquita Tugiono, MD
Address 0 0
Nucleus Network, Center for Clinical Studies Study Site
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications