INNA-051 Influenza Challenge Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 2a Study in Healthy Adult Participants Pre-treated With INNA-051 and Challenged With Influenza Virus

Conditions
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Influenza Prophylaxis

Intervention / Treatment
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* Drug: INNA-051
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent 18 to 55 years (inclusive) at time of consent In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that will interfere with participant safety Agree to use highly effective contraception Exclusion Criteria: History of, or currently active, symptoms or signs suggestive of URT or lower respiratory tract (LRT) infection within 4 weeks prior to the first study visit Any history or evidence of any other clinically significant or currently active systemic comorbidities including psychiatric disorders (includes participants with a history of depression and/or anxiety) Participants who have smoked ≥10 pack years at any time A total body weight ≤50 kg or body mass index (BMI) ≤18 kg/m2 or ≥35kg/m2. Pregnant or breast feeding Any significant abnormality altering the anatomy of the nose or nasopharynx that may interfere with the nasal assessments or viral challenge, clinically significant history of epistaxis, or any nasal or sinus surgery within 3 months of the first study visit vaccinations within the 4 weeks prior to the planned date of first dosing with IMP (10 days for SARS-CoV-2 vaccines, 6 months for influenza vaccine), or during the study Receipt of blood or blood products, or loss (including blood donations) of 470 mL or more of blood during the 3 months prior to dosing or planned in 3 months post. Receipt of any investigational product within 3 months (or 5 half-lives of the investigational product used in the other study, whichever is greater) prior to first dose with IMP, or 3 IMPs within prior 12 months, or prior administration with a virus from the same virus family as the challenge virus, or prior participation in another respiratory viral challenge study in the preceding 3 months Confirmed positive test for drugs of abuse or cotinine, history or presence of alcohol addiction, or excessive consumption of xanthine-containing substances A forced expiratory volume in 1 second (FEV1) <80% Positive HIV-1 or HIV-2 test, or positive test for hepatitis B or C

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INNA-051 arm 1<br>INNA-051 intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge | Drug: INNA-051<br>* Liquid for intra-nasal administration<br>|
| Experimental: INNA-051 arm 2<br>NNA-051 intranasal spray high dose administered once on each of Days -4 and -2 prior to viral challenge | Drug: INNA-051<br>* Liquid for intra-nasal administration<br>|
| Placebo Comparator: Placebo<br>Placebo intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge | Other: Placebo<br>* Liquid for intra-nasal administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | measurement of influenza viral load and duration of quantifiable measurements in nasopharyngeal swabs by qRT-PCR Duration of quantifiable qRT-PCR measurements | 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 |