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

Phase 1 Clinical Trial

Official title: 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

Clinical Trial 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)

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Phase 1

• NCT number: NCT03983876
• Study type: Interventional
• Source: Alvotech Swiss AG
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2019
• Completion date: December 3, 2019