NCT04557319

Safety and Pharmacokinetics of GNR-038 in Healthy Volunteers

An Open Study of the Safety and Pharmacokinetics of GNR-038 in Sequential Dose-increase Cohorts in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: AO GENERIUM · Industry
• Sex: All
• Age: 18 Months – 50 Years
• Healthy volunteers: Accepted

Summary

It is an open-label dose-escalating study in sequential cohorts to assess safety and pharmacokinetics of GNR-038.

Detailed description

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.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
BIOLOGICAL	GNR-038, 25 МЕ/kg	25 МЕ/kg once per study
BIOLOGICAL	GNR-038, 50 МЕ/kg	50 МЕ/kg once per study
BIOLOGICAL	GNR-038, 100 МЕ/kg	100 МЕ/kg once per study

Timeline

• Start date: 2020-03-10
• Primary completion: 2020-08-27
• Completion: 2020-08-27
• First posted: 2020-09-21
• Last updated: 2020-09-30

Locations

1 site across 1 country: Russia