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

NCT03254810 | Completed Phase 1

• 1 other identifier: SYN060-001
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (8)

• 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.

  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

  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

  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

  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

  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

  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

  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

  85 days

Secondary Outcomes (3)

• Adverse event incidence of SYN060 compared to adalimumab (Humira®) from North American and European sources

  85 days

• anti-SYN060 antibodies

  85 days

• anti-adalimumab antibodies

  85 days

Study Arms (3)

SYN060

EXPERIMENTAL

a single 0.57 mg/kg dose of SYN060

Biological: SYN060

Adalimumab North American source

ACTIVE COMPARATOR

a single 0.57 mg/kg dose of adalimumab from North American source

Biological: Adalimumab North American source

Adalimumab European source

ACTIVE COMPARATOR

a single 0.57 mg/kg dose of adalimumab from European source

Biological: Adalimumab European source

Interventions

SYN060 BIOLOGICAL

a single subcutaneous 0.57 mg/kg dose of SYN060

SYN060

Adalimumab North American source BIOLOGICAL

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

Adalimumab North American source

Adalimumab European source BIOLOGICAL

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

Adalimumab European source

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Synermore Biologics Co., Ltd.: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Niquita Tugiono, MD

  Nucleus Network, Center for Clinical Studies Study Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 21, 2017
• Study Start: September 26, 2017
• Primary Completion: July 17, 2018
• Study Completion: July 17, 2018
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)