Phase I study (Completed)
During 2013 and 2014, Hansa Medical conducted a clinical first-in-human Phase I study. The study was a randomized placebo controlled dose-escalation study with 29 (20 active plus 9 placebo) healthy subjects. The objectives were to assess safety, efficacy in IgG cleavage, pharmacokinetics and immunogenicity of imlifidase following intravenous administration. The starting dose was 0.01 mg/kg BW and the highest dose group received 0.24 mg/kg BW. Imlifidase was considered safe and it effectively degraded the plasma IgG. In July 2015, the results from the Phase I study was published in PLOS ONE.
Based on the data from this study, it was decided to move from healthy subjects into patients where it is possible to measure not only imlifidase effect on plasma IgG but also the effect on specific pathogenic IgG. The Phase I data suggested that imlifidase could prove to be a therapeutic option in several clinical conditions.