Phase 2a study of antiviral activity of CC-42344 in a human viral challenge model in healthy adults
Research type
Research Study
Full title
A Randomised, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity Against Influenza Infection, Safety, Tolerability, and Pharmacokinetics of CC-42344 Via a Human Viral Challenge Model in Healthy Participants.
IRAS ID
1007765
Contact name
Sam Lee
Contact email
Sponsor organisation
Cocrystal Pharma Inc.
Research summary
The purpose of this research is to test the effects of an experimental drug called CC-42344 and that it may be useful in treating infection with the influenza virus. Influenza virus causes an infectious disease commonly referred to as ‘the flu’. The Influenza virus can spread easily through the air, often by coughs and sneezes. The disease is often mild in healthy adults but can cause more severe symptoms in pregnant women, elderly people, people with a compromised immune system & those with chronic conditions like diabetes, asthma or heart failure. CC-42344 works by stopping the growth & spread of the influenza virus in the body. The approved treatments for the flu are drugs called zanamivir and oseltamivir, but new drugs are needed because flu virus may be becoming ‘resistant’ to these drugs. There remains a need to develop drugs with high effectiveness for providing longer & broader protection. Up to 96 healthy adult volunteers, aged 18-55 will be invited to participate in this research study with a minimum of 26 per group. The study consists of 3 stages: Screening, Quarantine & Follow-up. The study will consist of 3 groups. Following an initial first dose, Group 1 will be assigned the study drug twice a day for 5 days in total and Group 2 will be assigned the study drug in the morning and the placebo in the evening from D1 to D5. Group 3 will be assigned to the placebo and will receive this in the morning and evening from D1 to D5.
Subjects will be randomly assigned to receive placebo and/or the study drug as an oral capsule. The participants will enter quarantine on day -2/-1 and will be dosed with CC-42344 or placebo between Day 1 & Day 5. On Day 0 the participants will be inoculated with the influenza virus. After completion of the Quarantine phase, participants will need to return to the clinic approximately 20 days after for a follow-up visit (D28) to undergo tests.
The expected duration of study participation for a participant is approximately 4 months.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
23/SC/0183
Date of REC Opinion
8 Sep 2023
REC opinion
Further Information Favourable Opinion