NCT06160531

Influenza Viral Challenge Study of CC-42344 in Healthy Participants

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Cocrystal Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Participants in this study will be given either CC-42344 (one of two dose levels) or placebo orally for 5 days after receiving an influenza (flu) challenge virus. Participants will not know whether they are getting placebo or CC-42344. The amount of virus in nasal samples will be measured over time. Side effects and pharmacokinetics (the amount of CC-42344 in blood) will also be measured.

Detailed description

This is a single-center, phase 2a, randomized, double-blind, placebo-controlled study in healthy adult participants. The primary goal of this study is to assess the antiviral activity of orally administered CC-42344 in an influenza human viral challenge model, and to explore the impact of different dose levels on efficacy. In addition, the safety, tolerability, and pharmacokinetics will be assessed.

Conditions

• Influenza A

Interventions

Type	Name	Description
DRUG	CC-42344	Anti-influenza A agent
DRUG	Placebo	Matching placebo

Timeline

• Start date: 2023-11-25
• Primary completion: 2024-05-03
• Completion: 2024-07-18
• First posted: 2023-12-07
• Last updated: 2025-08-05

Locations

1 site across 1 country: United Kingdom