Influenza A
Conditions
Keywords
Tolerability, Antiviral, Viral challenge model
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.
Interventions
DRUGCC-42344
Anti-influenza A agent
DRUGPlacebo
Matching placebo
Sponsors
hVIVO Services Limited
Cocrystal Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Time to first confirmed nonquantifiable viral assessment | Day 1 to Day 8 | Determined by qRT-PCR 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 | — |
| Maximum viral load | Day 1 to Day 8 | Determined by qRT-PCR on nasal samples |
| 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 |
| Time to symptom resolution | Day 1 to Day 8 | — |
Countries
United Kingdom
Outcome results
None listed