Drug
IV Biosimilar
Study Design
Comparative BE with Reference product
PD and Immunogenicity assessments
Multiple sites in EU and US In-house for few days followed by daily/weekly follow up visits
Subject Recruitment
Total 390 subjects
AXIS as rescue site during Covid-19 peak to recruit up to 50 subjects
Study outcome
Studies completed within the sponsor target timeline
Some recruitment challenges due to peak Covid-19
