A FIH, SAD, MAD and FE study of PRX201848 in Healthy Male Subjects
Research type
Research Study
Full title
A First-in-Human, Double-Blind, Randomized, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Oral Doses of PRX201848 in Healthy Male Subjects; and the Effect of Food on the Pharmacokinetics of a Single Oral Dose of PRX201848 in Healthy Male Subjects
IRAS ID
258805
Contact name
Muna Albayaty
Contact email
Sponsor organisation
Proximagen LLC
Eudract number
2018-004504-19
Duration of Study in the UK
0 years, 8 months, 17 days
Research summary
This is a first-in-human (FIH), Phase I, single-centre study in up to 72 healthy male volunteers. \nThe main purpose of the study is to see how safe the study drug, PRX201848, is and how well the body tolerates the study drug after single and repeated doses, administered orally. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as pharmacokinetics [PK]). In addition, the study will investigate the effect of the study drug on the body (referred to as pharmacodynamics [PD]) and will explore the impact of the study drug on a certain enzyme.\nThe study comprises two parts. Single rising doses (Part 1) and repeated daily doses over 14 days (Part 2) will be administered to separate cohorts of healthy male volunteers in a double-blind, randomised, placebo-controlled study design. Part 1 will be further divided into Part 1a and Part 1b. In Part 1a, subsequent cohorts of participants will receive single ascending doses in the fasted state, in Part 1b, one cohort of participants from Part 1a will receive a single dose of PRX201848 after a high fat breakfast to investigate the effect of food on the PK and PD. \nEach study part includes a screening visit, treatment period and a follow-up visit. Eligible participants in Part 1 and Part 2 will stay inhouse for approximately 72 hours after the (last) dose.\nPRX201848 is being developed by Proximagen LLC for treatment of inflammatory disorders such as rheumatoid arthritis, osteoarthritis or non-alcoholic steatohepatitis.\nAs this is the first study with PRX201848 in humans, no human safety data is available yet. Based on the nonclinical safety data, no clinically significant undesirable effects are expected at the doses proposed.\n
REC name
London - Harrow Research Ethics Committee
REC reference
19/LO/0263
Date of REC Opinion
27 Mar 2019
REC opinion
Favourable Opinion