Safety, Tolerability, PK, and PD of KNS366
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single (Intravenous Infusion) and Multiple (Continuous Intravenous Infusion Over 7 Days) Doses of KNS366 In Healthy Adult Participants
IRAS ID
1006658
Contact name
Kate Watkins
Contact email
Sponsor organisation
Kynos Therapeutics Limited
Eudract number
2022-003179-41
ISRCTN Number
ISRCTN10496020
Research summary
KNS366 (The study medicine) is an experimental treatment for preventing damage to the kidneys caused by heart surgery. We hope the study medicine will work by blocking a protein known as KMO. KMO makes a substance called 3HK which is harmful in high levels and can damage organs such as the kidneys. People who’ve had heart surgery sometimes have kidney damage caused by increased blood levels of 3HK. By blocking KMO, we hope the study medicine will protect patients having heart surgery from kidney damage.
This is a 2-part study (Parts A and B) in up to 56 healthy men and women, aged 18–55 years. We’ll test single doses of the study medicine in Part A, and a single dose followed by a continuous slow injection in Part B. We aim to find out the study medicine’s side effects, blood levels, and whether it reduces the blood levels of 3HK.
The study medicine has never been given to humans before, so in each part we’ll start with a low dose and increase the dose as the study progresses.
In Part A, 2 groups of up to 12 participants will have 3 study sessions. In each session they’ll have a single dose of the study medicine or placebo as a slow injection over 30 minutes.
In Part B, up to 4 groups of 8 participants will have a single dose of the study medicine or placebo injected into a vein over 30 minutes, followed by a continuous slow injection for 7 days.
Participants will take up to 9 weeks to finish the study. They’ll make up to 2 outpatient visits and will stay on the ward 3 times for 4 nights each in part A or once for 11 nights in part B.
A pharmaceutical company, Kynos, is funding the study. The study will take place at 1 centre in London.
REC name
London - Westminster Research Ethics Committee
REC reference
22/LO/0757
Date of REC Opinion
21 Dec 2022
REC opinion
Further Information Favourable Opinion