Influenza Viral Challenge Study of CC-42344 in Healthy Participants

Last updated: July 31, 2025
Sponsor: Cocrystal Pharma, Inc.
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

CC-42344

Placebo

Clinical Study ID

NCT06160531
CC-42344-P2-001
CPI-CST-001
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • History of or current significant medical condition

  • Upper or lower respiratory tract infection within 4 weeks

  • Vaccination within 4 weeks

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: CC-42344
Phase: 2
Study Start date:
November 25, 2023
Estimated Completion Date:
July 18, 2024

Study 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.

Connect with a study center

  • Queen Mary BioEnterprises Innovation Centre

    London, E1 2AX
    United Kingdom

    Site Not Available

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