Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase 2, randomized, double-blind, placebo-controlled study of INNA-051 in healthy adults, administered prior to administration of an influenza challenge virus. This study will evaluate 2 active dose levels of INNA-051 and placebo.
Healthy participants will be administered 2 doses on INNA-051 intra-nasally and subsequently administered influenza virus as a challenge. Participants will be quarantined for 8 days. Study assessments will be performed during this period and they will monitored for symptoms of influenza infection.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INNA-051 arm 1 | Experimental | INNA-051 intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge |
|
| INNA-051 arm 2 | Experimental | NNA-051 intranasal spray high dose administered once on each of Days -4 and -2 prior to viral challenge |
|
| Placebo | Placebo Comparator | Placebo intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INNA-051 | Drug | Liquid for intra-nasal administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the antiviral effect of INNA-051 compared to placebo against influenza virus | Change in total viral load area under the curve (AUC) measured by quantitative reverse transcriptase-polymerase chain reaction (qRT PCR) in treated participants vs. placebo participants. | To Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | Treatment emergent adverse events in INNA-051 arms compared to placebo | To Day 8 |
| To evaluate the antiviral effect of INNA-051 in reducing viral load when compared to placebo |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Victoria Parker, MD | Hvivo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| hVIVO | London | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 12, 2023 | |
| Reset | Apr 8, 2024 | |
| Release | Sep 18, 2025 | |
| Reset | Oct 9, 2025 | |
| Release | Dec 22, 2025 | |
| Reset | Jan 13, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 12, 2023 | Apr 8, 2024 | |||
| Sep 18, 2025 |
| ID | Term |
|---|---|
| C000720267 | INNA-051 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Other |
Liquid for intra-nasal administration |
|
| To Day 8 |
| To evaluate the antiviral effect of INNA-051 in reducing detectable virus levels when compared to placebo | - Duration of quantifiable qRT-PCR measurements | To Day 8 |
| To evaluate the antiviral effect of INNA-051 in reducing incidence of infection when compared to placebo | Incidence of 2 quantifiable qRT PCR samples on 2 consecutive days | To Day 8 |
| To evaluate the antiviral effect of INNA-051 in reducing symptoms of influenza infection when compared to placebo | All symptoms will be self-reported by participants on a symptom diary card | To Day 8 |
| Oct 9, 2025 |
| Dec 22, 2025 | Jan 13, 2026 |