Testing CC-42344 for treating influenza in healthy adults
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
This study is testing a new drug called CC-42344 to see if it can help healthy adults fight off the flu after being exposed to the virus.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Cocrystal Pharma, Inc. Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT06160531 on ClinicalTrials.gov |
What this trial studies
This study evaluates the antiviral effects of CC-42344 in healthy adults who will receive either the drug or a placebo after being exposed to an influenza virus. Participants will be monitored for viral load in nasal samples, side effects, and how the drug is processed in the body over a five-day period. The study is randomized, double-blind, and placebo-controlled to ensure unbiased results. The primary aim is to determine the efficacy of different doses of CC-42344 in combating influenza.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-65 with a body weight of at least 50 kg and a BMI between 18 and 35.
Not a fit: Patients with significant medical conditions or recent respiratory infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new antiviral treatment for influenza, improving patient outcomes during flu seasons.
How similar studies have performed: Previous studies using antiviral agents in viral challenge models have shown promise, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy adults * Body weight ≥50 kg * Body mass index ≥18 kg/m2 and ≤35 kg/m2 * Serology results consistent with susceptibility to challenge virus infection Exclusion Criteria: * History of or current significant medical condition * Upper or lower respiratory tract infection within 4 weeks * Vaccination within 4 weeks
Where this trial is running
London
- Queen Mary BioEnterprises Innovation Centre — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Victoria Parker, MMBS — hVIVO Services Limited
- Study coordinator: Hardeep Johal, BSc
- Email: h.johal@hvivo.com
- Phone: 44 (0)7442 810912
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.