A FIH Study in EIDD-2801 [COVID-19]
Research type
Research Study
Full title
A Randomized, Double Blind, Placebo Controlled, First-in-Human Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of EIDD-2801 Following Oral Administration to Healthy Volunteers
IRAS ID
282287
Contact name
Jim Bush
Contact email
Sponsor organisation
Ridgeback Biotherapeutics
Eudract number
2020-001407-17
Duration of Study in the UK
0 years, 1 months, 23 days
Research summary
EIDD-2801 is an orally available direct-acting antiviral drug that is being studied for the treatment of several different RNA viruses, including influenza virus and the COVID-19 causing coronavirus. The drug works by interfering with the virus’s ability to reproduce itself, by causing changes to the RNA reproduction process resulting in mutations in the virus. With enough mutations, the virus is no longer able to quickly multiply. In animal models (studies in animals used to predict what might happen in humans), EIDD-2801 was shown to treat influenza, SARS, and MERS. This study is being done to look at the safety and tolerability of EIDD-2801 and to measure the amount of EIDD-2801 that gets into the bloodstream of healthy subjects who take the compound by mouth. The study is composed of 2 parts; Part 1 will assess the safety and tolerability of single doses of EIDD-2801 and Part 2 will assess the effect of food on EIDD 2801. After completion of each dosing cohort in Part 1, safety, tolerability, and PK data will be reviewed to determine if any of the halting rules have been met. If not, then the subsequent cohort may be dosed.\n\nFour cohorts are initially planned for the study; however, up to an additional 3 cohorts may be enrolled.
REC name
North East - York Research Ethics Committee
REC reference
20/NE/0109
Date of REC Opinion
8 Apr 2020
REC opinion
Further Information Favourable Opinion