A study to investigate safety, tolerability and PK of R552 (QSC202574)
Research type
Research Study
Full title
A Phase I, Single-Centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of R941552 (R552) in Healthy Subjects
IRAS ID
268680
Contact name
Lucy Yan
Contact email
Sponsor organisation
Rigel Pharmaceuticals, Inc.
Eudract number
2019-002520-32
Duration of Study in the UK
0 years, 7 months, 4 days
Research summary
The Sponsor is developing the test medicine, R552, for the potential treatment of a range of autoimmune and inflammatory diseases, where the immune system mistakes parts of the body as foreign and attacks it, causing inflammation (for example swelling and redness), as well as the potential to help neurodegenerative diseases (progressive loss of function in the brain cells). \n\nThe aim of this study is to look at the safety and tolerability of the test medicine. The study will also characterise the pharmacokinetic (PK - what the body does to the drug) profile of single and multiple oral doses of R552. The effect of food on the relative bioavailability (level of free drug present in the blood) will also be investigated. \n\nThe study will consist of 2 parts involving up to 94 healthy male and female volunteers of non-childbearing potential. \n\nIn Part 1A, up to 7 cohorts of 6 volunteers (42 volunteers in total) will receive a single dose of R552 or matching placebo in the fed or fasted state. Volunteers will be discharged 48 h post-dose. \n\nIn Part 1B (optional), up to 2 cohorts of 6 volunteers (12 volunteers in total) will receive a single oral dose of R552 in the fasted state. Volunteers will be discharged 48 h post-dose. \n\nIn Part 2, up to 5 cohorts of 8 volunteers (40 volunteers in total) will receive multiple oral doses of R552 for 14 days in the fed or fasted state. Volunteers will be discharged 48 h post-final dose.\n\nIn Part 1, volunteers will attend a follow up visit on Day 7.\nIn Part 2, volunteers will attend a follow up visit on Day 21.\n\n\n\n
REC name
Wales REC 2
REC reference
19/WA/0231
Date of REC Opinion
4 Sep 2019
REC opinion
Further Information Favourable Opinion