Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has been designed as a multicentre, randomised, double-blind study of AVT02 in
      healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02
      compared to EU-Humira and US licenced Humira (US-Humira), when administered as a single 40 mg
      SC dose.
    

Detailed description: 
      AVT02 is being developed as a biosimilar to Humira. EU-Humira and US-Humira have therefore
      been selected as the active control groups in this study.

      This study is designed as a multi-center, randomised, double-blind, 3-arm parallel study of
      AVT02 compared to EU-Humira and US-Humira in healthy adult subjects. The study is designed to
      evaluate the PK, safety and tolerability of AVT02 compared to EU-Humira and US-Humira when
      administered as a single dose (40 mg) SC injection.

      Subjects will be randomly assigned with a ratio of 1:1:1 to receive either AVT02 or EU-Humira
      or US-Humira on a single occasion on study Day 1. Both the site staff assessing the subjects
      and the subjects themselves will be blinded to the treatments being administered.

      The study consists of a screening period, admission and treatment period, assessment period
      and end of study 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 and tolerability
      assessments will be performed according to the study schedule (Table 6Table 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 end of study visit will occur at study Day 64 for final study assessments
    

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 diseases
Other intervention name(s): Humira ATC code L04AB04
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 arm trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science