Arthritis, RheumatoidPhase 1NCT03254810
Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects
A Phase 1 study testing SYN060, Adalimumab North American source and Adalimumab European source in people with Arthritis, Rheumatoid, run by Synermore Biologics Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- SYN060, Adalimumab North American source and Adalimumab European source
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Sep 2017to 17 Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects between 18 and 50 years of age, inclusive
- Body mass index between 18 and 30 kg/m², inclusive
- Female subjects physically capable of pregnancy (i.e., not sterilized and still menstruating or within 1 year of the last menses if menopausal) must:
- Agree to avoid pregnancy from the Study Day screening visit through six months after receipt of Study Drug.
- 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).
- Women of childbearing potential must have a negative serum pregnancy test within 24 hours preceding receipt of the dose.
- 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.
Who cannot join
- Acute illness on Study Day 1
- Oral temperature ≥37.5°C on Study Day 1
- Inability to discontinue daily medications other than oral contraceptives or other hormonal therapy.
- Receipt of an immunoglobulin or blood product within 90 days prior to Study Day 1
- Any receipt of adalimumab, or other licensed monoclonal antibody
- Any receipt of another investigational product within 4 weeks or 4 half-lives whichever is longer prior to Study Day 1
Show all 31Show fewer
- 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
- Abnormal screening urinalysis result that is, per the investigator, clinically significant, or a screening urine dipstick result of ≥2+ protein
- Positive screening urine test for illicit drugs (amphetamines, methamphetamines, barbiturates, benzodiazepine, cocaine, opiates, PCP, MDMA, methadone)
- History of systemic allergic reactions, to more than one medication.
- History or evidence of malignancy.
- Receipt of immunosuppressive medications other than inhaled or topical immunosuppressant drugs such as corticosteroids within 45 days prior to Study Day 1
- Hepatitis B surface antigen positive, HIV positive, hepatitis C antibody positive
- Uncontrolled Type 2 Diabetes or Type I diabetes
- History systemic fungal infection.
- Shared a residence within the last year with an individual on anti-tuberculosis treatment or with culture or smear positive tuberculosis
- 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
- 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
- History or evidence of tuberculosis infection
- Positive Quantiferon test
- Chest X ray with evidence of malignancy or chronic infection (such as tuberculosis or other)
- 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.
- Elective surgery that would interfere with participation.
- Live virus vaccination within 60 days and during the study.
- Blood donation less than 30 days prior to Study Day 1.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- SYN060, Adalimumab North American source, Adalimumab European source
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYN060Biological
a single subcutaneous 0.57 mg/kg dose of SYN060
Adalimumab North American sourceBiological
a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American source
Adalimumab European sourceBiological
a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from European source
| Study group | Role | What they receive |
|---|---|---|
| SYN060 | Experimental | a single 0.57 mg/kg dose of SYN060 Receives: Biological: SYN060 |
| Adalimumab North American source | Active comparator | a single 0.57 mg/kg dose of adalimumab from North American source Receives: Biological: Adalimumab North American source |
| Adalimumab European source | Active comparator | a single 0.57 mg/kg dose of adalimumab from European source Receives: Biological: Adalimumab European source |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 85 days
Cmax (maximum observed concentration)
Cmax will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Measured: 85 days
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
Measured: 85 days
Tmax (time of observed Cmax)
Tmax will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Measured: 85 days
t½ (elimination half-life)
t½ will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Measured: 85 days
λz (elimination rate constant)
λz will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Measured: 85 days
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
Measured: 85 days
Vz/F [apparent volume of distribution, calculated as Dose/ (λz x AUC0-inf)]
Vz/F will be estimated using non-compartmental analysis for SYN060 and adalimumab (Humira®) from North American and European sources
Measured: 85 days
Secondary outcomes (3)
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.
Measured: 85 days
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.
Measured: 85 days
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.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start26 Sep 2017
- Primary completion17 Jul 2018
- Study completion17 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synermore Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niquita Tugiono, MD, Principal investigator, Nucleus Network, Center for Clinical Studies Study Site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254810
- Sponsor's protocol ID
- SYN060-001
- Status last verified
- Nov 2018
- First submitted
- 16 Aug 2017
- Last updated
- 19 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03254810
- Acronym / sponsor ID
- SYN060-001
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Synermore Biologics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 17 Jul 2018 (actual)
- Study completion
- 17 Jul 2018 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SYN060 | Experimental | Biological: SYN060a single 0.57 mg/kg dose of SYN060 |
| Adalimumab North American source | Active comparator | Biological: Adalimumab North American sourcea single 0.57 mg/kg dose of adalimumab from North American source |
| Adalimumab European source | Active comparator | Biological: Adalimumab European sourcea single 0.57 mg/kg dose of adalimumab from European source |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female subjects between 18 and 50 years of age, inclusive
- Body mass index between 18 and 30 kg/m², inclusive
- Female subjects physically capable of pregnancy (i.e., not sterilized and still menstruating or within 1 year of the last menses if menopausal) must:
- Women of childbearing potential must have a negative serum pregnancy test within 24 hours preceding receipt of the dose.
- 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.
Key exclusion criteria (31 listed)
- Acute illness on Study Day 1
- Oral temperature ≥37.5°C on Study Day 1
- Inability to discontinue daily medications other than oral contraceptives or other hormonal therapy.
- Receipt of an immunoglobulin or blood product within 90 days prior to Study Day 1
- Any receipt of adalimumab, or other licensed monoclonal antibody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYN060a single subcutaneous 0.57 mg/kg dose of SYN060 | Biological | SYN060 |
| Adalimumab North American sourcea single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American source | Biological | Adalimumab North American source |
| Adalimumab European sourcea single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from European source | Biological | Adalimumab European source |
Primary outcome
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.
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
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
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
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
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
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
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
3 secondary outcomes
Adverse event incidence of SYN060 compared to adalimumab (Humira®) from North American and European sources
Time frame: 85 days
anti-SYN060 antibodies
Time frame: 85 days
anti-adalimumab antibodies
Time frame: 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niquita Tugiono, MD principal investigator
Nucleus Network, Center for Clinical Studies Study Site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYN060, Adalimumab North American source and Adalimumab European source in people with Arthritis, Rheumatoid, run by Synermore Biologics Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2018.