Influenza ProphylaxisPhase 2NCT05255822
INNA-051 Influenza Challenge Study
A Phase 2 study testing INNA-051 in people with Influenza Prophylaxis, run by ENA Respiratory Pty Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Prophylaxis
- What is being tested?
- INNA-051
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Feb 2022to 23 Aug 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- INNA-051, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INNA-051Drug
Liquid for intra-nasal administration
PlaceboOther
Liquid for intra-nasal administration
| Study group | Role | What they receive |
|---|---|---|
| INNA-051 arm 1 | Experimental | INNA-051 intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge Receives: 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 Receives: Drug: INNA-051 |
| Placebo | Placebo comparator | Placebo intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: To Day 8
Secondary outcomes (5)
Incidence of treatment emergent adverse events
Treatment emergent adverse events in INNA-051 arms compared to placebo
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: To Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start28 Feb 2022
- Primary completion23 Aug 2022
- Study completion23 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza ProphylaxisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENA Respiratory Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Victoria Parker, MD, Principal investigator, Hvivo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255822
- Sponsor's protocol ID
- INNA-051-IAV-HC-01
- Status last verified
- Jan 2023
- First submitted
- 27 Jan 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Study in Healthy Adult Participants Pre-treated With INNA-051 and Challenged With Influenza Virus
- ClinicalTrials.gov ID
- NCT05255822
- Acronym / sponsor ID
- INNA-051-IAV-HC-01
- Conditions
- Influenza Prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- ENA Respiratory Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 23 Aug 2022 (actual)
- Study completion
- 23 Aug 2022 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INNA-051 arm 1 | Experimental | Drug: INNA-051INNA-051 intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge |
| INNA-051 arm 2 | Experimental | Drug: INNA-051NNA-051 intranasal spray high dose administered once on each of Days -4 and -2 prior to viral challenge |
| Placebo | Placebo comparator | Other: PlaceboPlacebo intranasal spray low dose administered once on each of Days -4 and -2 prior to viral challenge |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INNA-051Liquid for intra-nasal administration | Drug | INNA-051 arm 1, INNA-051 arm 2 |
| PlaceboLiquid for intra-nasal administration | Other | Placebo |
Primary outcome
Evaluate the antiviral effect of INNA-051 compared to placebo against influenza virus
Time frame: To Day 8
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.
5 secondary outcomes
Incidence of treatment emergent adverse events
Time frame: To Day 8
To evaluate the antiviral effect of INNA-051 in reducing viral load when compared to placebo
Time frame: To Day 8
To evaluate the antiviral effect of INNA-051 in reducing detectable virus levels when compared to placebo
Time frame: To Day 8
To evaluate the antiviral effect of INNA-051 in reducing incidence of infection when compared to placebo
Time frame: To Day 8
To evaluate the antiviral effect of INNA-051 in reducing symptoms of influenza infection when compared to placebo
Time frame: To Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Parker, MD principal investigator
Hvivo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INNA-051 in people with Influenza Prophylaxis, run by ENA Respiratory Pty Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the antiviral effect of INNA-051 compared to placebo against influenza virus (time frame: To Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.