Influenza Viral InfectionsPhase 2NCT05507567
Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model
A Phase 2 study testing Neumifil in people with Influenza Viral Infections, run by Pneumagen Ltd. at 1 site in United Kingdom.
Trial summary
Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Viral Infections
- What is being tested?
- Neumifil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2022to 4 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent signed and dated by the participant and the investigator obtained before any assessment is performed.
- Adult male or female aged between 18 and 55 years old, inclusive, on the day prior to signing the consent form.
- A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2.
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the investigator.
- Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.
- Agree to use highly effective contraception
- Serosuitable for the challenge virus
Who cannot join
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT, LRT) infection within 4 weeks prior to the first study visit.
- Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the investigator, may interfere with a participant completing the study and necessary investigations. Includes a history of depression or anxiety.
- Any participants who have smoked ≥ 10 pack years at any time.
- Females who are pregnant or breastfeeding
- Any history of anaphylaxis or history of severe allergic reactions to any foods, drugs, insect bites or stings or any known allergy to tetracycline antibiotics.
- Venous access deemed inadequate for the phlebotomy and cannulation demands of the study.
Show all 20Show fewer
- a) Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and, in particular, any of the nasal assessments or viral challenge b) Any evidence of nasal inflammation or nasal polyps within the last month c) Any clinically significant history of epistaxis (large nosebleeds) within the last 3 months of the first study visit and/or history of being hospitalised due to epistaxis on any previous occasion.
- Any nasal or sinus surgery within 3 months of the first study visit. Prior or Concomitant Medications and Assessments
- a) Evidence of vaccinations within the 4 weeks prior to the planned date of first dosing with IMP.
- Intention to receive any vaccination(s) before the last day of follow-up (with the exception of vaccinations recommended for COVID19 as defined by Medicines and Healthcare Regulatory Agency (MHRA)/government vaccination guidelines). No travel restrictions apply after the Day 28 (±3 days) follow-up visit.
- Receipt of influenza vaccine (or another IMP relating to treatment of influenza) in the last 6 months prior to the planned date of viral challenge OR a diagnosis of influenza or influenza-like illness confirmed by a physician within the last 2 months prior to screening.
- Receipt of blood or blood products, or loss (including blood donations) of 550 mL or more of blood during the 3 months prior to the planned date of first dosing with IMP or planned during the 3 months after the final follow-up visit.
- a) Receipt of any investigational drug within 3 months (or 5 half-lives of the IMP used in the other study, whichever is greater), prior to the planned date of first dosing with IMP.
- Receipt of 3 or more investigational drugs within the previous 12 months prior to the planned date of first dosing with IMP.
- Prior inoculation with a virus from the same virus-family as the challenge virus.
- Prior participation in another human viral challenge study with a respiratory virus in the preceding 3 months.
- Use or anticipated use during the conduct of the study of concomitant medications
- Confirmed positive test for drugs of misuse and cotinine on first study visit
- 13 Recent history or presence of alcohol addiction, or excessive use of alcohol
- 14. A FEV1 <80%, a FVC <80% predicted, or an FEV1/FVC ratio <0.7. 15. Positive HIV, hepatitis B virus, or hepatitis C virus test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 2a Study To Assess the Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza, Via a Human Viral Challenge Model in Healthy Adult Participants
Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants
Read the detailed description
This is a single-centre, randomized, double-blind, placebo-controlled study in healthy adult participants to assess the pre-exposure prophylactic antiviral activity of Neumifil via a human viral challenge model.
Participants will enter the quarantine unit on Day -4.
Participants will be randomized to receive either active (single dose), active (multiple dose) or placebo in a 3:3:4 ratio followed by influenza viral challenge on Day 0.
Participants will leave the unit on Day 8, provided that no virus is detected by a qualitative virus antigen test and the participant has no clinically significant symptoms. A final follow-up will be performed on Day 28.
- Conditions
- Influenza Viral Infections
- Being tested
- Neumifil, Placebo
- Keywords
- Influenza, Human Challenge, Prophylaxis
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeumifilDrug
Liquid for intranasal spray administration
PlaceboDrug
Liquid for intranasal spray administration
| Study group | Role | What they receive |
|---|---|---|
| Neumifil multiple dose prophylactic treatment | Experimental | Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge Receives: Drug: Neumifil |
| Neumifil single dose prophylactic treatment | Experimental | Neumifil intranasal spray administered as a single dose and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge Receives: Drug: Neumifil; Drug: Placebo |
| Placebo | Placebo comparator | Intranasal spray administered as 3 single daily doses prior to viral challenge Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Symptomatic Influenza Infection
Number of subjects with quantifiable viral shedding on 2 consecutive days AND with any symptom score of grade 2 or greater at a single time point.
Viral shedding was measured by RT-qPCR. Eleven symptoms were assessed by questionnaire and were graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).
Measured: Day 1 to Day 8
Severity of Symptoms
Change in Peak Total Symptom Score (TSS) as measured by graded symptom scoring system collected 3 times daily; symptom questionnaire was graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. The range was 0 to 33.
Measured: Day 1 to Day 8
Secondary outcomes (7)
Area Under the Curve (AUC) Over Time of Total Symptom Score (TSS)
Participants completed a self-assessment symptom score 3 times daily, graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. Range 0 to 33
Measured: Day 1 to Day 8
Viral Shedding Over Time
Measurement of influenza viral load (VL) area under the curve (VL-AUC) of quantifiable measurements by RT-qPCR in nasal samples.
The AUC is expressed as the log to the base 10 copies in a mL of nasal fluid multiplied by the time in days [(log10 copies/mL)*day]. The higher the viral load AUC, by PCR, the worse the outcome.
Measured: Day 1 (pm) to Day 8 (am)
Viral Shedding Over Time
Measurement of influenza viral load (VL) in nasal samples over time (VL-AUC) measured by viral culture. Nasal secretions were cultured and the Tissue Culture Infectious Dose (TCID50) calculated. The AUC of log to the base 10 of the TCID50 in each mL of nasal secretions, multiplied by the time in days [(log10 TCID50/mL)*day] was calculated. The higher the viral load AUC by culture, the worse the outcome.
Measured: Day 1 (pm) to Day 8 (am)
Weight of Nasal Discharge
Measurement of total weight of mucus produced by participants. The total weight of used tissues was measured to assess the weight of mucus produced. The greater the weight of the tissues the more mucus produced and the worse the outcome.
Measured: Day 1 (am) to Day 8 (am)
Nasal Discharge
The number of tissues used by participants were counted. The greater the number of tissues used the worse the outcome.
Measured: Day 1 (am) to Day 8 (am)
Adverse Events, Solicited
Number of participants reporting a solicited adverse event during the treatment period of IMP
Measured: From intake of first dose of IMP (Day -3) up to 12 hours post the last IMP dose (Day -1)
Adverse Events, Unsolicited
Number of participants reporting treatment emergent adverse events, unsolicited
Measured: From intake of first dose of IMP on Day -3 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start12 Aug 2022
- Primary completion4 May 2023
- Study completion4 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza Viral InfectionsStudies 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
- Model description
- Randomized, Double-blind, Placebo-controlled study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pneumagen Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Geoff Kitson, Study director, gkitson@propharmapartners.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507567
- Sponsor's protocol ID
- PNG-NMF-201
- Status last verified
- Oct 2024
- First submitted
- 17 Aug 2022
- Last updated
- 28 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kitson G, Byford M, Cass L, Howat D, Kohn B, Bisquera A, Catchpole A, Noulin N, Thomson D. A Phase II, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of HEX17, a Novel Broad-Spectrum Antiviral Drug, in a Controlled Human Infection Model of Influenza Challenge. Infect Dis Ther. 2025 Aug;14(8):1697-1714. doi: 10.1007/s40121-025-01179-2. Epub 2025 Jul 2.
PubMed 40593264
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase 2a Study To Assess the Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza, Via a Human Viral Challenge Model in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05507567
- Acronym / sponsor ID
- PNG-NMF-201
- Conditions
- Influenza Viral Infections
- Keywords
- Influenza, Human Challenge, Prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Pneumagen Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 4 May 2023 (actual)
- Study completion
- 4 May 2023 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Posted 28 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to assess the efficacy and safety of a multiple dose regimen and a single dose regimen of intranasal Neumifil, administered prior to challenge with Influenza virus in healthy adult participants
Detailed description
This is a single-centre, randomized, double-blind, placebo-controlled study in healthy adult participants to assess the pre-exposure prophylactic antiviral activity of Neumifil via a human viral challenge model.
Participants will enter the quarantine unit on Day -4.
Participants will be randomized to receive either active (single dose), active (multiple dose) or placebo in a 3:3:4 ratio followed by influenza viral challenge on Day 0.
Participants will leave the unit on Day 8, provided that no virus is detected by a qualitative virus antigen test and the participant has no clinically significant symptoms. A final follow-up will be performed on Day 28.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, Double-blind, Placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Neumifil multiple dose prophylactic treatment | Experimental | Drug: NeumifilNeumifil intranasal spray administered as 3 single daily doses prior to viral challenge |
| Neumifil single dose prophylactic treatment | Experimental | Drug: Neumifil, Drug: PlaceboNeumifil intranasal spray administered as a single dose and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge |
| Placebo | Placebo comparator | Drug: PlaceboIntranasal spray administered as 3 single daily doses prior to viral challenge |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent signed and dated by the participant and the investigator obtained before any assessment is performed.
- Adult male or female aged between 18 and 55 years old, inclusive, on the day prior to signing the consent form.
- A total body weight ≥50 kg and body mass index (BMI) ≥18 kg/m2 and ≤35kg/m2.
- In good health with no history, or current evidence, of clinically significant medical conditions, and no clinically significant test abnormalities that that will interfere with participant safety, as defined by medical history, physical examination, (including vital signs), ECG, and routine laboratory tests as determined by the investigator.
- Participants will have a documented medical history either prior to entering the study or following medical history review with the study physician at screening.
Key exclusion criteria (20 listed)
- History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT, LRT) infection within 4 weeks prior to the first study visit.
- Any history or evidence of any clinically significant or currently active cardiovascular, respiratory, dermatological, gastrointestinal, endocrinological, haematological, hepatic, immunological (including immunosuppression), metabolic, urological, renal, neurological, or psychiatric disease and/or other major disease that, in the opinion of the investigator, may interfere with a participant completing the study and necessary investigations. Includes a history of depression or anxiety.
- Any participants who have smoked ≥ 10 pack years at any time.
- Females who are pregnant or breastfeeding
- Any history of anaphylaxis or history of severe allergic reactions to any foods, drugs, insect bites or stings or any known allergy to tetracycline antibiotics.
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 |
|---|---|---|
| NeumifilLiquid for intranasal spray administration | Drug | Neumifil multiple dose prophylactic treatment, Neumifil single dose prophylactic treatment |
| PlaceboLiquid for intranasal spray administration | Drug | Neumifil single dose prophylactic treatment, Placebo |
Primary outcome
Incidence of Symptomatic Influenza Infection
Time frame: Day 1 to Day 8
Number of subjects with quantifiable viral shedding on 2 consecutive days AND with any symptom score of grade 2 or greater at a single time point. Viral shedding was measured by RT-qPCR. Eleven symptoms were assessed by questionnaire and were graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).
Severity of Symptoms
Time frame: Day 1 to Day 8
Change in Peak Total Symptom Score (TSS) as measured by graded symptom scoring system collected 3 times daily; symptom questionnaire was graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. The range was 0 to 33.
7 secondary outcomes
Area Under the Curve (AUC) Over Time of Total Symptom Score (TSS)
Time frame: Day 1 to Day 8
Viral Shedding Over Time
Time frame: Day 1 (pm) to Day 8 (am)
Viral Shedding Over Time
Time frame: Day 1 (pm) to Day 8 (am)
Weight of Nasal Discharge
Time frame: Day 1 (am) to Day 8 (am)
Nasal Discharge
Time frame: Day 1 (am) to Day 8 (am)
Adverse Events, Solicited
Time frame: From intake of first dose of IMP (Day -3) up to 12 hours post the last IMP dose (Day -1)
Adverse Events, Unsolicited
Time frame: From intake of first dose of IMP on Day -3 to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40593264Kitson G, Byford M, Cass L, Howat D, Kohn B, Bisquera A, Catchpole A, Noulin N, Thomson D. A Phase II, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of HEX17, a Novel Broad-Spectrum Antiviral Drug, in a Controlled Human Infection Model of Influenza Challenge. Infect Dis Ther. 2025 Aug;14(8):1697-1714. doi: 10.1007/s40121-025-01179-2. Epub 2025 Jul 2.
Related trials for Influenza Viral Infections
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Geoff Kitson study director
gkitson@propharmapartners.com
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 Neumifil in people with Influenza Viral Infections, run by Pneumagen 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 7 inclusion and 20 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 28 Oct 2024. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Symptomatic Influenza Infection (time frame: Day 1 to Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05507567, which also lists 1 linked publication.
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 28 Oct 2024.