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INNA-051 Influenza Challenge Study

Primary Purpose

Influenza Prophylaxis

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

INNA-051

Placebo

About this trial

This is an interventional prevention trial for Influenza Prophylaxis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

hVIVO

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

INNA-051 arm 1

INNA-051 arm 2

Placebo

Arm Description

INNA-051 intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge

NNA-051 intranasal spray high dose administered once on each of Days -4 and -2 prior to viral challenge

Placebo intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of treatment emergent adverse events

Treatment emergent adverse events in INNA-051 arms compared to placebo

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 evaluate the antiviral effect of INNA-051 in reducing detectable virus levels when compared to placebo

- Duration of quantifiable qRT-PCR measurements

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 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

Full Information

NCT ID

NCT05255822

First Posted

January 27, 2022

Last Updated

January 17, 2023

Sponsor

ENA Respiratory Pty Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05255822

Brief Title

INNA-051 Influenza Challenge Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

February 28, 2022 (Actual)

Primary Completion Date

August 23, 2022 (Actual)

Study Completion Date

August 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ENA Respiratory Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

INNA-051 arm 1

Arm Type

Experimental

Arm Description

INNA-051 intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge

Arm Title

INNA-051 arm 2

Arm Type

Experimental

Arm Description

NNA-051 intranasal spray high dose administered once on each of Days -4 and -2 prior to viral challenge

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge

Intervention Type

Drug

Intervention Name(s)

INNA-051

Intervention Description

Liquid for intra-nasal administration

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Liquid for intra-nasal administration

Primary Outcome Measure Information:

Title

Evaluate the antiviral effect of INNA-051 compared to placebo against influenza virus

Description

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

Secondary Outcome Measure Information:

Title

Incidence of treatment emergent adverse events

Description

Treatment emergent adverse events in INNA-051 arms compared to placebo

Time Frame

To Day 8

Title

To evaluate the antiviral effect of INNA-051 in reducing viral load when compared to placebo

Description

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

Title

To evaluate the antiviral effect of INNA-051 in reducing detectable virus levels when compared to placebo

Description

- Duration of quantifiable qRT-PCR measurements

Time Frame

To Day 8

Title

To evaluate the antiviral effect of INNA-051 in reducing incidence of infection when compared to placebo

Description

Incidence of 2 quantifiable qRT PCR samples on 2 consecutive days

Time Frame

To Day 8

Title

To evaluate the antiviral effect of INNA-051 in reducing symptoms of influenza infection when compared to placebo

Description

All symptoms will be self-reported by participants on a symptom diary card

Time Frame

To Day 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Victoria Parker, MD

Organizational Affiliation

Hvivo

Official's Role

Principal Investigator

Facility Information:

Facility Name

hVIVO

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

INNA-051 Influenza Challenge Study

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