Influenza Viral Challenge Study of CC-42344 in Healthy Participants

Phase 2

Recruiting

• Conditions: Influenza A
• Interventions: Drug: CC-42344; Drug: Placebo

• Registration Number: NCT06160531
• Lead Sponsor: Cocrystal Pharma, Inc.

Brief 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.

Study Timeline

• Status Verified: 2023-11
• Study Start: 2023-11-25
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-06
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

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Exclusion Criteria

• History of or current significant medical condition
• Upper or lower respiratory tract infection within 4 weeks
• Vaccination within 4 weeks

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CC-42344 Dose 1	CC-42344	Low dose group
CC-42344 Dose 2	CC-42344	High dose group
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maximum viral load	Day 1 to Day 8	Determined by viral culture on nasal samples
Time to first confirmed nonquantifiable viral assessment	Day 1 to Day 8	Determined by viral culture on nasal samples
VL-AUC of influenza challenge virus	Day 1 to Day 8	Determined by viral culture on nasal samples
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)	Day 1 to Day 28	Number of participants with AEs
Incidence of serious adverse events (SAEs)	Day 1 to Day 28	Number of participants with SAEs
Incidence of AEs related to viral challenge	Day 1 to Day 28	Number of participants with AEs related to viral challenge
Incidence of SAEs related to viral challenge	Day 1 to Day 28	Number of participants with SAEs related to viral challenge

Trial Locations

Locations (1)

Queen Mary BioEnterprises Innovation Centre; 🇬🇧 London, United Kingdom