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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
123
hVIVO
London, United Kingdom
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.
Time frame: To Day 8
Incidence of treatment emergent adverse events
Treatment emergent adverse events in INNA-051 arms compared to placebo
Time frame: To Day 8
To evaluate the antiviral effect of INNA-051 in reducing viral load when compared to placebo
* measurement of influenza viral load and duration of quantifiable measurements in nasopharyngeal swabs by qRT-PCR * Duration of quantifiable qRT-PCR measurements
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: To Day 8
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