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

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.

Study Overview

• Status: Completed
• Conditions: Influenza A
• Intervention / Treatment: Drug: Placebo; Drug: CC-42344

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, E1 2AX
    • Queen Mary BioEnterprises Innovation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching placebo
Experimental: CC-42344 Dose 1; Low dose group	Drug: CC-42344; Anti-influenza A agent
Experimental: CC-42344 Dose 2; High dose group	Drug: CC-42344; Anti-influenza A agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the influenza viral load-time curve (VL-AUC) of influenza challenge virus	Determined by quantitative real time reverse transcriptase polymerase chain reaction (qRT-PCR) on nasal samples	Day 1 to Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum viral load	Determined by qRT-PCR on nasal samples	Day 1 to Day 8
Time to first confirmed nonquantifiable viral assessment	Determined by qRT-PCR on nasal samples	Day 1 to Day 8
VL-AUC of influenza challenge virus	Determined by viral culture on nasal samples	Day 1 to Day 8
Maximum viral load	Determined by viral culture on nasal samples	Day 1 to Day 8
Time to first confirmed nonquantifiable viral assessment	Determined by viral culture on nasal samples	Day 1 to Day 8
Area under the curve over time of total clinical symptoms score (TSS-AUC)		Day 1 to Day 8
Peak TSS		Day 1 to Day 8
Peak daily symptom score		Day 1 to Day 8
Time to symptom resolution		Day 1 to Day 8
Incidence of adverse events (AEs)	Number of participants with AEs	Day 1 to Day 28
Incidence of serious adverse events (SAEs)	Number of participants with SAEs	Day 1 to Day 28
Incidence of AEs related to viral challenge	Number of participants with AEs related to viral challenge	Day 1 to Day 28
Incidence of SAEs related to viral challenge	Number of participants with SAEs related to viral challenge	Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Cocrystal Pharma, Inc.
• Collaborators: hVIVO Services Limited
• Investigators: Principal Investigator: Victoria Parker, MMBS, hVIVO Services Limited

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2023
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Tolerability; Antiviral; Viral challenge model
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human
• Other Study ID Numbers: CC-42344-P2-001; CPI-CST-001 (Other Identifier: hVIVO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No