Hereditary Angioedema Clinical Trial
Official title:
An Open Study of the Safety and Pharmacokinetics of GNR-038 in Sequential Dose-increase Cohorts in Healthy Volunteers
It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-038.
Hereditary angioedema (HAE) is a rare potentially life-threatening genetically determined
disease associated with a deficiency or impairment of C1 esterase inhibitor (C1 inhibitor)
functional activity. Main clinical manifestations of HAE are recurrent mucous membranes edema
and localization of the derma deep layers. Attack persist from several hours to several days
and disappear without a trace in most cases, without additional therapy.
The prevalence of the disease in the world is from 1:10 000 to 1: 150 000. The
plasma/recombinant C1 inhibitor use to compensate for its deficiency or insufficient
functional activity in patients with HAE is recommended both for severe and for long-term and
short-term (before surgical interventions and dental manipulations) prophylaxis.
GNR-038 is a recombinant C1 inhibitor (rhC1-inh), which is a complete structural and
functional analogue of the plasma C1 inhibitor.
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