Safety PK PD 3part SAD MAD FE study with KVD818 in healthy adult males
Research type
Research Study
Full title
A Phase 1, Randomised, Double-blind, Placebo controlled, 3 part, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Food effect of a Novel Plasma Kallikrein Inhibitor in Healthy Adult Male Subjects.
IRAS ID
202385
Contact name
Muna Albayaty
Contact email
Sponsor organisation
KalVista Pharmaceuticals Ltd.
Eudract number
2016-000970-39
Duration of Study in the UK
0 years, 6 months, 18 days
Research summary
This clinical research study is being sponsored by KalVista Pharmaceuticals Ltd.\n\nThe new medicine tested in this study is a compound called KVD818. KalVista is developing KVD818 as treatment for vascular permeability (fluid leaking from the blood vessels) disorders where kallikrein is implicated. Kallikrein is an enzyme that breaks down protein and has been recognised as a key mediator of increased vascular permeability (increased leakage) through the production of bradykinin which leads to the widening of blood vessels in turn.\n\nConditions include:\n• Diabetic macular oedema (DME): swelling of the retina in diabetes mellitus due to leaking of fluid from blood vessels within the macula; the macula is the central portion of the retina, a small area rich in cones, the specialized nerve endings that detect colour and upon which daytime vision depends on,\n• Hereditary angioedema (HAE): blood vessels are affected; a HAE attack can result in rapid swelling of the hands, feet, limbs, face, intestinal tract, larynx (voice box), or trachea (windpipe) due to severe leakage of fluid from the blood vessels.\n\nKVD818 supresses kallikrein which plays a role in blood clotting, blood pressure, inflammation and associated pain and therefore this should lead to improved blood clotting, lower blood pressure and reduced inflammation and associated pain.\n\nThe main purposes of the study are to:\n• See how safe KVD818 is and how well it is tolerated after dosing (single doses of KVD818 taken with or without food).\n• See how KVD8181 is taken up, metabolised (chemically broken down); distributed through the body and excreted. This is called the Pharmacokinetics (PK).\n• See how KVD818 affects the body. This is called the pharmacodynamics (PD) (as an exploratory [an optional informative, not main] goal).\n
REC name
London - Brent Research Ethics Committee
REC reference
16/LO/0590
Date of REC Opinion
26 May 2016
REC opinion
Further Information Favourable Opinion