A first-in-human study of KVD824 in healthy volunteers
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Pharmacokinetics of KVD824 Following Administration of Single and Multiple Ascending Oral Doses; followed by a crossover food effect sub-study in Healthy Volunteers.
IRAS ID
257245
Contact name
Annelize Koch
Contact email
Sponsor organisation
KalVista Pharmaceuticals Ltd
Eudract number
2018-003860-29
Duration of Study in the UK
0 years, 4 months, 18 days
Research summary
This is a 3 part study which will evaluate the safety and pharmacokinetics of a new investigational drug called KVD824. This drug is being developed as an oral treatment for the management of Diabetic Macular Oedema (DMO), a condition of swelling in the light sensitive part of the eye which causes problems with vision.\n\nCurrently treatment for this condition involves injections or laser treatments to the eye which can be uncomfortable and invasive for patients. Therefore there is a need to develop treatments which can be taken as an oral tablet.\n\nThe first part of the study will investigate KVD824 and placebo when given as a single dose. Doses will be evaluated in an ascending manner in up to 8 cohorts in the first part of the study. Within each successive cohort the dose will be increased, provided it is considered acceptable to do so.\nThe second part of the study will investigate KVD824 and placebo when given as multiple doses over a period of 7 days.\nThe third part of the study will investigate the effect of food on the activity of KVD824 when given after an overnight fast or following a high fat breakfast.\n\nThe main purpose for this study is to evaluate the safety, pharmacokinetics (how the body handles the drug) and pharmacodynamics (how the drug works in the body) of KVD824. This study will be conducted in up to 116 healthy males, at Simbec, a research facility located in Wales, UK.
REC name
Wales REC 2
REC reference
19/WA/0006
Date of REC Opinion
17 Jan 2019
REC opinion
Favourable Opinion