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NCT Number: NCT06160531

Influenza Viral Challenge Study of CC-42344 in Healthy Participants

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.

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Key information

Conditions

Influenza A

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Queen Mary BioEnterprises Innovation Centre

London, E1 2AX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC-42344

Drug

Anti-influenza A agent

Placebo

Drug

Matching placebo

Primary outcomes

  1. Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus

    Time frame: Day 1 to Day 8

    Determined by quantitative real time reverse transcriptase polymerase chain reaction (qRT-PCR) on nasal samples

Secondary outcomes

  1. Maximum viral load

    Time frame: Day 1 to Day 8

    Determined by qRT-PCR on nasal samples

  2. Time to first confirmed nonquantifiable viral assessment

    Time frame: Day 1 to Day 8

    Determined by qRT-PCR on nasal samples

  3. VL-AUC of influenza challenge virus

    Time frame: Day 1 to Day 8

    Determined by viral culture on nasal samples

  4. Maximum viral load

    Time frame: Day 1 to Day 8

    Determined by viral culture on nasal samples

  5. Time to first confirmed nonquantifiable viral assessment

    Time frame: Day 1 to Day 8

    Determined by viral culture on nasal samples

  6. Area under the curve over time of total clinical symptoms score (TSS-AUC)

    Time frame: Day 1 to Day 8

  7. Peak TSS

    Time frame: Day 1 to Day 8

  8. Peak daily symptom score

    Time frame: Day 1 to Day 8

  9. Time to symptom resolution

    Time frame: Day 1 to Day 8

  10. Incidence of adverse events (AEs)

    Time frame: Day 1 to Day 28

    Number of participants with AEs

  11. Incidence of serious adverse events (SAEs)

    Time frame: Day 1 to Day 28

    Number of participants with SAEs

  12. Incidence of AEs related to viral challenge

    Time frame: Day 1 to Day 28

    Number of participants with AEs related to viral challenge

  13. Incidence of SAEs related to viral challenge

    Time frame: Day 1 to Day 28

    Number of participants with SAEs related to viral challenge

Sponsors and collaborators

Lead sponsor

Cocrystal Pharma, Inc.

Industry

Collaborators

  • hVIVO Services Limited

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2023
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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