INNA-051 Influenza Challenge Study

NCT05255822 | Completed Phase 2 DMC

• 1 other identifier: INNA-051-IAV-HC-01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza Prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Incidence of treatment emergent adverse events

  To Day 8

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

  To Day 8

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

  To Day 8

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

  To Day 8

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

  To Day 8

Study Arms (3)

INNA-051 arm 1

EXPERIMENTAL

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

Drug: INNA-051

INNA-051 arm 2

EXPERIMENTAL

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

Drug: INNA-051

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

INNA-051 DRUG

Liquid for intra-nasal administration

INNA-051 arm 1; INNA-051 arm 2

Placebo OTHER

Liquid for intra-nasal administration

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ENA Respiratory Pty Ltd: lead

Study Sites (1)

hVIVO

London, United Kingdom

Location

MeSH Terms

Interventions

INNA-051

Study Officials

• Victoria Parker, MD

  Hvivo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 25, 2022
• Study Start: February 28, 2022
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)