* A Phase 1 Multi-part Trial to Evaluate the PK Profile and Food Effect of KVD824 (QSC204866)
Research type
Research Study
Full title
A Phase 1, Multiple Part, Open Label Trial to Evaluate the Pharmacokinetic Profile of KVD824 Following Administration of KVD824 Gastro Retentive Formulation Prototypes in Healthy Volunteers
IRAS ID
1004853
Contact name
Richard Bedford
Contact email
Sponsor organisation
KalVista Pharmaceuticals Ltd.
Eudract number
2021-006855-33
ISRCTN Number
ISRCTN14984568
Research summary
The Sponsor is developing the test medicine, KVD824, for the potential prevention of hereditary angioedema (HAE) attacks. HAE is a disorder defined by recurring incidents of severe swelling. The most common areas of the body to develop swelling are the limbs, face, intestines and airways.\n\nThis 3-part healthy volunteer trial will try to identify how new recipes (formulations) of the test medicine are taken up by the body (pharmacokinetics), the level of test medicine in the blood following oral dosing (relative bioavailability) and try to provide additional safety and tolerability information for the test medicine. The trial may also explore what the test medicine does to the body (pharmacodynamics) and the effect of food and the timing of dosing.\n\nThis trial will take place in 1 non-NHS site, enrolling up to 62 male and female volunteers in total, aged 30 to 55 for Part 1 and 18 to 55 for Parts 2 and 3.\n\nIn Part 1, volunteers will receive single oral doses of the test medicine across 6 periods. A radiolabelled recipe of the test medicine may be used in up to 5 periods so images of inside the volunteers bodies can be taken to monitor how the test medicine moves in the gastrointestinal system.\n\nPart 2 is optional. If utilised, volunteers will receive single oral doses of the test medicine across up to 6 periods. \n\nIn Parts 1 and 2, volunteers will be discharged on Day 3 of each period.\n\nIn Part 3, volunteers in two cohorts will receive once or twice daily doses of the test medicine for 7 days and will be discharged on Day 9.\n\nIn all parts, volunteers will receive a follow up phone call 5 to 7 days post final dose.\n\nVolunteers’ blood and urine will be taken throughout the trial for analysis of the test medicine and for their safety. \n\nVolunteers are expected to be involved in this trial for 21 weeks for Part 1, 9 weeks for Part 2 and 7 weeks for Part 3 from screening to the follow up call.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/FT/0040
Date of REC Opinion
10 Mar 2022
REC opinion
Further Information Favourable Opinion