APPA
Research type
Research Study
Full title
A Phase 1, partially Blind, Placeb-Controlled, Ascending Single and Multiple Oral Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects and Osteoarthritis Patients administered APPA-1.
IRAS ID
224956
Contact name
Seema / Charlotte Chauhan / Rawcliffe
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2017-000833-29
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
APPA trial is a placebo controlled trial aiming to determine the safety and tolerability of ascending single and multiple oral doses of APPA-1 along with the single and multiple oral dose pharmacokinetics (what the body does to a drug) of APPA-1 constituents (paeonol/apocynin) in healthy subjects and osteoarthritis patients. \n\nThe trial will be conducted at the Clinical Research Unit (CRU) at the Royal Liverpool and Broadgreen University Hospital Trust and will be split into two parts. \nPart A will involve 20 healthy subjects studied in 5 groups (group A1 to A5) of 4 subjects receiving a single dose. Groups A1 to A4 will be male subjects only, Group A5 will consist of female subjects only to assess potential gender effects. In each group, 3 subjects will receive APPA-1 and 1 will receive placebo, by way of randomisation. All doses will be administered in a fasted state on day 1. Subjects in group A3 will receive a second dose at least 7 days after first dose, which will be administered 30 minutes after a high fat breakfast to assess potential food effect. Subjects will be reviewed 7-10 days post their last dose.\n\nThere will be a minimum of 10 days between dose escalations.\n\nPart B will involve 12 patients with osteoarthritis studied in 3 groups (groups B1 to B3) of 4 subjects receiving multiple doses. Osteoarthritis patients will be assessed to determine the potential for pain relief. In each group, 3 patients will received APPA-1 and 1 will receive placebo. The dose levels and dietary state for dosing in part B will be subject to review of safety and pharmacokinetic data from Part A. For all patients, up to two times daily dosing will occur on Days 1 to 13 inclusive and a final single dose will be administered on day 14.\n\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0443
Date of REC Opinion
2 Nov 2017
REC opinion
Further Information Favourable Opinion