PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)
Condition: Phase 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed as a multicentre, randomised, open label study of AVT02 in
      healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in
      Pre-Filled Syringe compared to AVT02 in Autoinjector Pen. Both arms will use single dose of
      40mg of AVT02 (Adalimumab)
    

Detailed description: 
      This study is designed as a multi-center, randomized, open-label, 2-arm parallel study of
      AVT02 administered via a PFS either manually via an autoinjector, in healthy adult subjects.

      A total of 204 subjects will be recruited into this study and will be randomly assigned with
      a ratio of 1:1 to receive either AVT02 manually or via autoinjector. As the study is
      open-label, both the site staff and the subjects themselves will know which treatments are
      being administered.

      The study consists of a screening period, admission and treatment period, assessment period
      and end of study (EOS) visit. Subjects will undertake a screening visit between Day -28 and
      Day -1 to determine eligibility in the study. Those subjects that meet the eligibility
      criteria will be admitted to the study site on the evening prior to dosing (Day -1) when
      continued eligibility will be assessed.

      On Day 1 prior to dosing, baseline assessments will be performed. Subjects will then be dosed
      according to the randomization schedule. Following dosing, PK, safety, tolerability and
      immunogenicity assessments will be performed according to the study schedule (Table 6).
      Subjects will remain confined to the study site from Day -1 to Day 3 (48 hours post-dose).
      Subjects will return to the study site on Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 12,
      Day 15, Day 22, Day 29, Day 36, Day 43, Day 50 and Day 57.

      An EOS visit will occur at study Day 64 for final study assessments. The EOS visit will also
      be the early termination visit if required (to be completed within 7 days of early
      termination wherever possible).
    

Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention description(s): AVT02, a proposed similar biological product (biosimilar) of Humira which contains adalimumab . Adalimumab is a recombinant, fully human monoclonal immunoglobulin G1 (IgG1) antibody that binds specifically and with high affinity to the soluble and transmembrane forms of tumor necrosis factor (TNF)-α thereby inhibiting the binding of TNF-α with its receptor, and inhibiting TNF -α's biological function.
Tumor necrosis factor-α is a naturally occurring cytokine that is key to normal inflammatory and immune responses. Elevated levels of TNF-α are found in the synovial fluid of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients and psoriasis plaques and play an important role in both the pathologic inflammation and joint destruction that are hallmarks of these inflammatory disease
Other intervention name(s): Humira ATC code L04AB0
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is an open-label, 2-arm parallel study of AVT02 (Administered via a PFS either manually via an autoinjector, in healthy adult subjects. The subjects in both arms will receive the same dose of AVT02, but in two different delivery modes.
Masking: None (Open Label)
Primary purpose: Treatment