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
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.
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