* A FIH SAD, FE, DDI Study in KRP-A218
Research type
Research Study
Full title
A First-in-Human, Phase I, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of KRP-A218 in Healthy Subjects, Including Food-Effect and Drug-drug Interaction with Itraconazole
IRAS ID
292824
Contact name
Jim Bush
Contact email
Sponsor organisation
Kyorin Pharmaceutical Company Limited
Eudract number
2020-004687-26
Clinicaltrials.gov Identifier
Research summary
Summary of Research
KRP-A218 is a novel, orally active, antiviral agent. It is intended to work against certain ribonucleic acid (RNA) viruses, such as human rhinovirus (HRV) and enteroviruses (EV) infections. Phosphatidylinositol 4-kinase beta (PI4KB) is a human host cell factor that is required by viruses such as HRVs and EVs to replicate within human cells. KRP-A218 is an adenosine triphosphate (ATP)-competitive and subtype specific inhibitor of PI4KB which shows broad-spectrum antiviral activity against HRVs and EVs by PI4KB inhibition. HAR-1234 is the active ingredient of KRP-A218.
This Phase I study will consist of 3 parts; Parts A, B, and C. The primary objective is to evaluate the safety and tolerability of single and multiple oral doses of KRP-A218 in healthy volunteers.
Part A will comprise a double-blind, randomized, placebo-controlled, single-dose escalation design and will enrol healthy male and female subjects (female subjects in group A2b only). Part A will include an evaluation of the effect of sex on the pharmacokinetics (PK) (how much of the drug gets into the blood stream and how quickly it is removed) of HAR-1234 by comparing dosing with a single dose of KRP-A218 in females versus dosing in males (Groups A2a and A2b). Part A will also include an evaluation of the effect of food on the PK of HAR-1234 in Group A2a which will be a 2-period arm comparing a single dose of KRP-A218 in fed conditions versus in fasted conditions.
Part B will comprise a double-blind, randomized, placebo-controlled, multiple-dose escalation design and will enrol healthy male subjects.
Part C will comprise an open-label, fixed-sequence design, enrolling healthy male subjects to investigate the effect of multiple oral doses of itraconazole on the single oral dose PK of HAR-1234 in healthy subjects.
REC name
London - Riverside Research Ethics Committee
REC reference
21/FT/0023
Date of REC Opinion
2 Apr 2021
REC opinion
Further Information Favourable Opinion