CSL Behring Initiates Study of Subcutaneous Administration of C1-esterase Inhibitor in Patients with Hereditary Angioedema

Phase I/II study to establish safety and clinical pharmacology with various doses of subcutaneous formulation of human C1-esterase inhibitor

04-May-2012 - USA

CSL Behring announced that it has initiated an international phase I/II study of a volume-reduced, subcutaneous formulation of C1-esterase inhibitor (C1-INH) concentrate in patients with hereditary angioedema (HAE). Part of the COMPACT (Clinical Studies for Optimal Management in Preventing Angioedema with Low-Volume Subcutaneous C1-inhibitor Replacement Therapy) program, the study will evaluate the pharmacokinetics, pharmacodynamics and safety of various doses of this presentation of C1-INH.

The open-label study will enroll adult patients with HAE type I or II. After an initial intravenous injection of C1-INH, each participant will be assigned to receive a single subcutaneous injection of the volume-reduced formulation of C1-INH twice a week for four weeks. Subjects will participate in two such periods with two different doses of volume-reduced C1-INH. Throughout the study, researchers will monitor C1-INH levels in the blood, as well as assess the safety and tolerability of the formulation at different doses.

Other news from the department research and development

Most read news

More news from our other portals

So close that even
molecules turn red...