INNA-051 Influenza Challenge Study

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza Prophylaxis
• Intervention / Treatment: Drug: INNA-051; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Hvivo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ENA Respiratory Pty Ltd
• Investigators: Principal Investigator: Victoria Parker, MD, Hvivo

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2022
• Primary Completion (Actual): August 23, 2022
• Study Completion (Actual): August 23, 2022

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 25, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: INNA-051-IAV-HC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No