*SAD,MAD and food effect trial to evaluate safety, tolerability, and PK of AQ280 in healthy subjects
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose and Food Effect Evaluation Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of AQ280 in Healthy Subjects
IRAS ID
1005473
Contact name
Anneli Tinnerholm
Contact email
Sponsor organisation
Aqilion AB
ISRCTN Number
ISRCTN14453297
Research summary
AQ280 belongs to a class of drugs known as highly selective JAK-1 inhibitors. JAK-1 inhibitors interrupt the inflammatory pathway in the body. It is hoped that AQ280 will be an effective new treatment for a condition called eosinophilic oesophagitis, a chronic, allergic inflammatory condition of the oesophagus (the tube connecting the mouth to the stomach).
Part A will comprise a single dose, sequential group, escalating-dose design; also incorporating a single group, 2 period crossover arm investigating the effect of dosing AQ280 with food compared to dosing whilst fasting. Approximately 40 participants are planned to be studied in 5 cohorts (Cohorts A1 to A5; with one of the cohorts including the food-effect evaluation). In each cohort, 6 participants will receive AQ280 and 2 participants will receive placebo. Each participant will reside at the study site from Day -1 to Day 3 of the treatment period and a safety follow-up phone call will be conducted 1 week after dosing. The Day 1 dose will be administered in the fasted state in all cohorts except for treatment period 2 of the food effect cohort where it will be administered after eating a high fat breakfast.
Part B will comprise a multiple dose, sequential group, escalating-dose design. Approximately 24 participants are planned to be studied in 3 cohorts (Cohorts B1 to B3). In each cohort, 6 participants will receive AQ280 and 2 participants will receive placebo. Each participant will reside at the study site from Day -1 to Day 9. Dosing is planned to be once daily on Days 1 to 7 and a safety follow-up visit will be conducted 1 week after the final dose.
The total duration of study participation for each participant is anticipated to be approximately 6 weeks (8 weeks for the food effect cohort) in Part A and 7 weeks in Part B.
Lay summary not available at this time
REC name
London - Riverside Research Ethics Committee
REC reference
22/FT/0063
Date of REC Opinion
6 Jun 2022
REC opinion
Further Information Favourable Opinion