INNA-051 Influenza Challenge Study

NCT ID: NCT05255822

Last Updated: 2023-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-28
• Study Completion Date: 2022-08-23

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.

Conditions

Influenza Prophylaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

INNA-051 arm 1

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

Group Type: EXPERIMENTAL

INNA-051

Intervention Type: DRUG

Liquid for intra-nasal administration

INNA-051 arm 2

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

Group Type: EXPERIMENTAL

INNA-051

Intervention Type: DRUG

Liquid for intra-nasal administration

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Liquid for intra-nasal administration

Interventions

INNA-051

Liquid for intra-nasal administration

Intervention Type: DRUG

Placebo

Liquid for intra-nasal administration

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ENA Respiratory Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Victoria Parker, MD

Role: PRINCIPAL_INVESTIGATOR

Hvivo

Locations

hVIVO

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

INNA-051-IAV-HC-01

Identifier Type: -

Identifier Source: org_study_id