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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03254810
Ethics application status
Date submitted
16/08/2017
Date registered
21/08/2017

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
Treatment: Other - SYN060
Treatment: Other - Adalimumab North American source
Treatment: Other - 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


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

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

Treatment: Other: Adalimumab European source
a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from European source
Intervention code [1] 0 0
Treatment: Other
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)
Timepoint [1] 0 0
85 days
Primary outcome [2] 0 0
Cmax (maximum observed concentration)
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)]
Timepoint [3] 0 0
85 days
Primary outcome [4] 0 0
Tmax (time of observed Cmax)
Timepoint [4] 0 0
85 days
Primary outcome [5] 0 0
t½ (elimination half-life)
Timepoint [5] 0 0
85 days
Primary outcome [6] 0 0
?z (elimination rate constant)
Timepoint [6] 0 0
85 days
Primary outcome [7] 0 0
CL/F (apparent body clearance, calculated as Dose/AUC0-inf)
Timepoint [7] 0 0
85 days
Primary outcome [8] 0 0
Vz/F [apparent volume of distribution, calculated as Dose/ (?z x AUC0-inf)]
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
Timepoint [1] 0 0
85 days
Secondary outcome [2] 0 0
anti-SYN060 antibodies
Timepoint [2] 0 0
85 days
Secondary outcome [3] 0 0
anti-adalimumab antibodies
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
Sex
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
26/09/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/07/2018
Sample size
Target
Accrual to date
Final
94
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03254810