Influenza Viral Challenge Study of CC-42344 in Healthy Participants

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Influenza A

Intervention / Treatment
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* Drug: CC-42344
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolerability, Antiviral, Viral challenge model