NCT03983876

PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)

Multi-center, Randomized, Open-Label, 2-Arm Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of AVT02 Administered Subcutaneously Via Prefilled Syringe or Autoinjector in Healthy Adult Volunteers (ALVOPAD PEN)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Alvotech Swiss AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Phase 1

Interventions

Type	Name	Description
DRUG	Adalimumab	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

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-12-03
• Completion: 2019-12-03
• First posted: 2019-06-12
• Last updated: 2022-05-04

Locations

2 sites across 1 country: New Zealand