NCT02193113

A Phase I Single Ascending Dose Study of the Intravitreal Plasma Kallikrein Inhibitor KVD001 in Subjects With DME

An Open Label, Single Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacodynamics of a Novel Intravitreal Plasma Kallikrein Inhibitor in Subjects With Central Involved Diabetic Macular Edema and Reduced Vision

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: KalVista Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study to investigate the safety, tolerability of the novel plasma kallikrein inhibitor, KVD001 in subjects with diabetic macular edema. The study is the first step to investigate the hypothesis that plasma kallikrein plays an important role in the disease process behind diabetic macular edema in many patients

Detailed description

The plasma kallikrein-kinin system has long been recognized as a key player in inflammatory processes, capillary leakage and angiogenesis in various organs. Recent work suggests that plasma kallikrein is central to the pathogenesis of Diabetic Macular Edema (DME) and that activation of the enzyme contributes to the excessive retinal vascular permeability leading to DME. Among different persons with DME, plasma kallikrein contributes both independently in some, and in association with Vascular Endothelial Growth Factor (VEGF) in others. However, the effect of plasma kallikrein appears to be independent of VEGF. Thus, growing scientific evidence points to plasma kallikrein inhibitors as an exciting potential new therapeutic opportunity directed at a novel VEGF-independent pathway that may reduce retinal vascular permeability and treat DME, in patients whose disease process is, at least in part, driven by the plasma kallikrein pathway. This is an open label, single ascending dose study to investigate the safety, tolerability and pharmacodynamics of a novel plasma kallikrein inhibitor administered by intravitreal (IVT) injection in subjects with central involved diabetic macular edema and reduced vision.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	KVD001 Injection	A novel plasma kallikrein inhibitor

Timeline

• Start date: 2014-07-18
• Primary completion: 2015-06-04
• Completion: 2015-06-04
• First posted: 2014-07-17
• Last updated: 2017-03-03

Locations

5 sites across 1 country: United States