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| ID | Type | Description | Link |
|---|---|---|---|
| CPI-CST-001 | Other Identifier | hVIVO |
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| Name | Class |
|---|---|
| hVIVO Services Limited | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC-42344 Dose 1 | Experimental | Low dose group |
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| CC-42344 Dose 2 | Experimental | High dose group |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-42344 | Drug | Anti-influenza A agent |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria Parker, MMBS | hVIVO Services Limited | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary BioEnterprises Innovation Centre | London | E1 2AX | United Kingdom |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 25, 2025 | |
| Reset | Dec 8, 2025 | |
| Release | Dec 16, 2025 | |
| Reset | Jan 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 25, 2025 | Dec 8, 2025 | |||
| Dec 16, 2025 |
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| Placebo |
| Drug |
Matching placebo |
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| 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 |
| Jan 6, 2026 |