Two part study to investigate a new drug called KVD900
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, single ascending dose study of the safety, tolerability, and pharmacokinetics of KVD900 followed by a crossover sub-study of KVD900 formulations in healthy male volunteers.
IRAS ID
237562
Contact name
Annelize Koch
Contact email
Sponsor organisation
KalVista Pharmaceuticals Ltd
Eudract number
2017-003520-73
Duration of Study in the UK
0 years, 3 months, 23 days
Research summary
This is study will evaluate the activity of a new drug KVD900. This drug being developed to inhibit an enzyme called plasma kallikrein and may be useful in diseases where this enzyme has known activity such as hereditary angioedema (HAE) which is a rare genetic disorder that causes swelling under the skin (angioedema)\n \nTreatment for an HAE attack includes medication given through a vein by an intravenous (IV) line or underneath the skin. Antihistamines (drugs usually used to treat allergies) and other traditional treatments used for angioedema do not work well for HAE.\n \nThis study will compare KVD900 to placebo. Doses will be evaluated in an ascending manner. Within each successive cohort the dose will be increased, provided it is considered acceptable to do so. The study will also evaluate at least 2 formulations of KVD900. The main purpose for this study is to evaluate the safety and pharmacokinetics (drug in the body) of KVD900. This study will be conducted in healthy normal male volunteers at Simbec, a research facility located in Wales, UK.\n
REC name
Wales REC 1
REC reference
17/WA/0373
Date of REC Opinion
13 Dec 2017
REC opinion
Further Information Favourable Opinion