drugset / Trial / NCT03983876

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

NCT03983876

Phase 1 Completed 207 enrolled Alvotech Swiss AG
RandomizedParallel-groupOpen-labelTreatment

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)

Timeline

Start
2019-07-01
Primary completion
2019-12-03
Completion
2019-12-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Adalimumab Monoclonal antibody 40 mg Subcutaneous

Indications

No indication recorded.