Safety Study on IdeS in Healthy Volounteers

Phase 1 Completed 29 enrolled Hansa Biopharma AB

RandomizedSingle-groupTriple-blindTreatment

Summary

This is a first in man study to assess safety and tolerability of the IgG cleaving enzyme Immunoglobuli G degrading enzyme of streptococcus pyogenes (IdeS).

Timeline

Start: 2013-02
Primary completion: 2013-12
Completion: 2014-02

Publications

Winstedt L, Jarnum S, Nordahl EA, Olsson A, Runstrom A, Bockermann R, Karlsson C, Malmstrom J, Palmgren GS, Malmqvist U, Bjorck L, Kjellman C. Complete Removal of Extracellular IgG Antibodies in a Randomized Dose-Escalation Phase I Study with the Bacterial Enzyme IdeS--A Novel Therapeutic Opportunity. PLoS One. 2015 Jul 15;10(7):e0132011. doi: 10.1371/journal.pone.0132011. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Imlifidase	Protein / enzyme biologic	0.24 mg/kg	Intravenous

Indications

No indication recorded.