Viral Respiratory Tract InfectionPhase 1NCT05093530
Safety and Tolerability of Single and Multiple Doses of Neumifil
A Phase 1 study testing Neumifil in people with Viral Respiratory Tract Infection, run by Pneumagen Ltd. at 1 site in United Kingdom.
Trial summary
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of Neumifil, administered intranasally. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Viral Respiratory Tract Infection
- What is being tested?
- Neumifil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Oct 2021to 5 Apr 2022
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteer, aged 18-60 years.
- BMI (Quetelet index) in the range 18.0-30.9 kg/m2.
- Able to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
- Agree to follow the contraception requirements of the trial
- Agree not to donate blood or blood products during the study and for up to 3 months after the administration of the trial medication.
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- Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value at the screening visit, calculated using National Health and Nutrition Examination Survey (NHANES) reference. If a subject's FEV1 or FVC is outside that range at the screening visit, the test may be repeated once on another day.
- Registered with a General Practitioner (GP) in the UK (Part A only).
- Willingness to give written consent to have data entered into The Overvolunteering Prevention System (TOPS).
Who cannot join
- Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception.
- Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that in the opinion of the investigator could interfere with the objectives of the trial or the safety of the volunteer.
- Presence or history of acute or chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
- Presence or history of respiratory disease, including (but not limited to) asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, emphysema, requiring acute or chronic medication.
- Presence of nasal polyps or significant nasal abnormalities.
- Symptoms of respiratory illness (including, but not limited to, runny nose, sore throat, sneezing, coughing or wheezing) at the screening visit or before dosing on Day 1.
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- Tympanic temperature > 37.5°C at the screening visit or before dosing on Day 1.
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
- History of psychiatric disease, as determine by the investigator.
- History or presence of malignant disease.
- Immune-suppressed status, resulting from either disease or medication, as determined by the investigator.
- Presence or history of severe adverse reaction to any drug or the excipients of Neumifil.
- Known allergy to tetracycline antibiotics.
- Use of a prescription medicine (except HRT in female subjects), including oral contraceptives, during the 28 days before the first dose of trial medication, or use of an over-the-counter medicine, with the exception of acetaminophen (paracetamol) and vitamin or nutritional supplements, during the 7 days before the first dose of trial medication.
- Receipt of an investigational product (including prescription medicines) as part of another clinical trial within the 3 months before admission to this study; in the follow-up period of another clinical trial at the time of screening for this study.
- Receipt of a COVID-19 vaccine within 7 days before the first dose of trial medication, or anticipate receiving a COVID-19 vaccine within the 7 days after a (final) dose of trial medication.
- Presence or history of drug or alcohol abuse, or regular intake of more than 14 units of alcohol weekly.
- Use of cigarettes or nicotine-containing products during the 6 months before first dose of trial medication.
- Blood pressure and heart rate in supine position at the screening examination outside the ranges: blood pressure 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40-100 beats/min. Triplicate measurements will be made (at least 2 min apart), and a mean value outside the above ranges will lead to exclusion. Repeat measurements (in triplicate) are permitted if values are borderline (ie values that are within 5 mm Hg for blood pressure or 5 beats/min for heart rate) or if requested by the investigator. Subjects can be included if the repeat value is within range or still borderline but deemed not clinically significant by the investigator.
- QTcF value, of > 450 msec (men) or > 470 msec (women); or QRS duration
- ≥ 120 msec, measured on 12-lead ECG at the screening visit. Triplicate measurements will be made, and a mean value used to determine eligibility. A repeat (in triplicate) is also allowed on one occasion for determination of eligibility.
- Possibility that the volunteer will not cooperate with the requirements of the protocol.
- Positive test for hepatitis B surface antigen, hepatitis C or HIV. NOTE:
- participants with positive hepatitis C antibody owing to resolved disease can be included only if a hepatitis C ribonucleic acid (RNA) test is negative.
- Positive test for SARS-CoV-2 (polymerase chain reaction; PCR) or suspected exposure to the SARS-CoV-19 virus during the 14 days before screening.
- Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
- Objection by GP to volunteer entering trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research (HMR)
London, NW10 7EW
About this study
Official title: A Two-part, Randomized, Double-blind, Placebo Controlled, Ascending Dose Study to Assess the Safety and Tolerability of Single and Multiple Doses of Neumifil (a Novel Drug Candidate With Potential for Treatment of COVID-19)
This is a Phase 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of Neumifil, administered intranasally.
Read the detailed description
Part A will include up to 36 healthy subjects in up to 5 groups. 6 subjects will be enrolled in Groups A1-A3 and 9 subjects will be enrolled in Groups A4 and A5. All subjects will receive a single intranasal dose of Neumifil or placebo. In Groups A1-A3, 4 subjects will receive Neumifil and 2 will receive matching placebo. In Groups A4 and A5, 6 subjects will receive Neumifil and 3 will receive matching placebo. The planned dose levels are: 0.028 mg (Group A1), 0.085 mg (Group A2), 0.28 mg (Group A3), 0.885 mg (Group A4), and 2.8 mg (Group A5). Additional dose levels may be assessed in up to 2 optional groups of up to 9 subjects each (Groups A6 and A7).
Subjects will be screened within 35 days before their dose of trial medication and reside at the Investigator site from the day before their dose (Day -1) until approximately 24 hours after dosing (Day 2). They will return for a follow-up visit on Day 8-9.
Part B will include up to 24 healthy subjects in up to 3 groups of 8 subjects (Groups B1-B3). Subjects will receive once-daily intranasal doses of Neumifil or placebo for 7 days. In each group, 6 subjects will receive Neumifil and 2 subjects will receive matching placebo.
The starting dose level (dose and dose regimen) for Group B1 will be decided after review of safety and tolerability data from at least 3 dose levels in Part A, and will be no higher than a dose that has previously been shown to cause no safety concerns in Part A . An additional dose level may be explored in 1 optional group of up to 8 subjects (Group B4).
Subjects will be screened within 35 days before their dose of trial medication and reside. at the Investigator site from the day before their first dose (Day -1) until about 24 hours after their last dose (Day 8). Subjects will attend an outpatient visit on Days 15-16. They will return for a follow-up visit on Days 21-23.
During the study, dose levels for study groups will be determined by a Safety Review Committee in accordance with criteria defined in the study protocol and the Investigator site operating procedures. Dose levels will only be increased if the safety and tolerability of previous dose levels are considered to be acceptable by the Safety Review Committee.
- Conditions
- Viral Respiratory Tract Infection
- Being tested
- Neumifil, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeumifilDrug
Also called HEX17
Neumifil contains the active ingredient HEX17, a multivalent, glycan-targeting carbohydrate binding module (CBM). HEX17 CBM is suspended in an aqueous buffer solution containing 20 mM sodium phosphate, 50 mM NaCl (at pH 6.3), 5 % (v/v) glycerol and 0.5 % (v/v) polysorbate 80.
PlaceboDrug
Aqueous buffer solution containing 20 mM sodium phosphate, 50 mM NaCl (at pH 6.3), 5 % (v/v) glycerol and 0.5 % (v/v) polysorbate 80.
| Study group | Role | What they receive |
|---|---|---|
| Neumifil | Experimental | Neumifil will be administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril, with adjusted concentrations of solution to enable dose ranging. Participants in Part A will receive a single dose of Neumifil and participants in Part B will receive once daily doses of Neumifil for 7 days according to the randomization.
Ascending single doses for Part A are anticipated to be 0.028mg (group A1), 0.085mg (group A2), 0.28mg (group A3), 0.885mg (group A4) and 2.8mg (group A5). Two further groups of up to 9 subjects may be investigated. The planned dose levels may change following review of the safety and tolerability of previous doses. The maximum dose will not exceed 2.8mg.
The starting dose level (dose and dose regimen) in Part B will be determined following review of the safety and tolerability of at least 3 dose levels in part A and subsequent dose levels will be determined following review of the safety and tolerability of previous doses. Receives: Drug: Neumifil |
| Placebo | Placebo comparator | Placebo will be administered intranasally using an Aptar deliver system. Each dose will consist of 0.5ml to each nostril. Participants in Part A will receive a single dose of placebo according to the randomization and participants in Part B will receive once daily doses of placebo for 7 days according to the randomization schedule. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Treatment Emergent Adverse Events
Number of participants with Treatment Emergent Adverse Events
Measured: 7 days
Part B: Treatment Emergent Adverse Events
Number of participants with Treatment Emergent Adverse Events
Measured: 14 days after last dose
Part A: Clinically Significant Changes in Safety Tests
Number of participants with clinically significant changes in:vital signs (heart rate, blood pressure, respiratory rate, pulse oximetry and temperature), 12-lead electrocardiogram (ECG), Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), physical examination, nasal examination, laboratory safety tests (haematology, biochemistry and urinalysis), tolerability questionnaire
Measured: 7 days
Part B:Clinically Significant Changes in Safety Tests
Number of participants with clinically significant changes in: vital signs (heart rate, blood pressure, respiratory rate, pulse oximetry and temperature), 12-lead electrocardiogram (ECG), FEV1, FVC, physical examination, nasal examination, laboratory safety tests (haematology, biochemistry and urinalysis), tolerability questionnaire
Measured: 14 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start12 Oct 2021
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
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.
- Other trials for Viral Respiratory Tract InfectionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 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.uk.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05093530
- Sponsor's protocol ID
- PNG-NMF-101
- Status last verified
- Jan 2024
- First submitted
- 29 Sep 2021
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Randomized, Double-blind, Placebo Controlled, Ascending Dose Study to Assess the Safety and Tolerability of Single and Multiple Doses of Neumifil (a Novel Drug Candidate With Potential for Treatment of COVID-19)
- ClinicalTrials.gov ID
- NCT05093530
- Acronym / sponsor ID
- PNG-NMF-101
- Conditions
- Viral Respiratory Tract Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pneumagen Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Posted 11 Jan 2024
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 1, single-centre, randomised, placebo-controlled first in human study in healthy subjects. The study will assess the safety and tolerability of single-ascending (Part A) and multiple-ascending (Part B) doses of Neumifil, administered intranasally.
Detailed description
Part A will include up to 36 healthy subjects in up to 5 groups. 6 subjects will be enrolled in Groups A1-A3 and 9 subjects will be enrolled in Groups A4 and A5. All subjects will receive a single intranasal dose of Neumifil or placebo. In Groups A1-A3, 4 subjects will receive Neumifil and 2 will receive matching placebo. In Groups A4 and A5, 6 subjects will receive Neumifil and 3 will receive matching placebo. The planned dose levels are: 0.028 mg (Group A1), 0.085 mg (Group A2), 0.28 mg (Group A3), 0.885 mg (Group A4), and 2.8 mg (Group A5). Additional dose levels may be assessed in up to 2 optional groups of up to 9 subjects each (Groups A6 and A7).
Subjects will be screened within 35 days before their dose of trial medication and reside at the Investigator site from the day before their dose (Day -1) until approximately 24 hours after dosing (Day 2). They will return for a follow-up visit on Day 8-9.
Part B will include up to 24 healthy subjects in up to 3 groups of 8 subjects (Groups B1-B3). Subjects will receive once-daily intranasal doses of Neumifil or placebo for 7 days. In each group, 6 subjects will receive Neumifil and 2 subjects will receive matching placebo.
The starting dose level (dose and dose regimen) for Group B1 will be decided after review of safety and tolerability data from at least 3 dose levels in Part A, and will be no higher than a dose that has previously been shown to cause no safety concerns in Part A . An additional dose level may be explored in 1 optional group of up to 8 subjects (Group B4).
Subjects will be screened within 35 days before their dose of trial medication and reside. at the Investigator site from the day before their first dose (Day -1) until about 24 hours after their last dose (Day 8). Subjects will attend an outpatient visit on Days 15-16. They will return for a follow-up visit on Days 21-23.
During the study, dose levels for study groups will be determined by a Safety Review Committee in accordance with criteria defined in the study protocol and the Investigator site operating procedures. Dose levels will only be increased if the safety and tolerability of previous dose levels are considered to be acceptable by the Safety Review Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Neumifil | Experimental | Drug: NeumifilNeumifil will be administered intranasally using an Aptar delivery system. Each dose will consist of 0.5ml to each nostril, with adjusted concentrations of solution to enable dose ranging. Participants in Part A will receive a single dose of Neumifil and participants in Part B will receive once daily doses of Neumifil for 7 days according to the randomization. Ascending single doses for Part A are anticipated to be 0.028mg (group A1), 0.085mg (group A2), 0.28mg (group A3), 0.885mg (group A4) and 2.8mg (group A5). Two further groups of up to 9 subjects may be investigated. The planned dose levels may change following review of the safety and tolerability of previous doses. The maximum dose will not exceed 2.8mg. The starting dose level (dose and dose regimen) in Part B will be determined following review of the safety and tolerability of at least 3 dose levels in part A and subsequent dose levels will be determined following review of the safety and tolerability of previous doses. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be administered intranasally using an Aptar deliver system. Each dose will consist of 0.5ml to each nostril. Participants in Part A will receive a single dose of placebo according to the randomization and participants in Part B will receive once daily doses of placebo for 7 days according to the randomization schedule. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male or female volunteer, aged 18-60 years.
- BMI (Quetelet index) in the range 18.0-30.9 kg/m2.
- Able to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
- Agree to follow the contraception requirements of the trial
Key exclusion criteria (27 listed)
- Woman who is pregnant or lactating, or pre-menopausal woman who is sexually active and not using a reliable method of contraception.
- Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that in the opinion of the investigator could interfere with the objectives of the trial or the safety of the volunteer.
- Presence or history of acute or chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
- Presence or history of respiratory disease, including (but not limited to) asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis, emphysema, requiring acute or chronic medication.
- Presence of nasal polyps or significant nasal abnormalities.
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 |
|---|---|---|
| NeumifilAlso: HEX17Neumifil contains the active ingredient HEX17, a multivalent, glycan-targeting carbohydrate binding module (CBM). HEX17 CBM is suspended in an aqueous buffer solution containing 20 mM sodium phosphate, 50 mM NaCl (at pH 6.3), 5 % (v/v) glycerol and 0.5 % (v/v) polysorbate 80. | Drug | Neumifil |
| PlaceboAqueous buffer solution containing 20 mM sodium phosphate, 50 mM NaCl (at pH 6.3), 5 % (v/v) glycerol and 0.5 % (v/v) polysorbate 80. | Drug | Placebo |
Primary outcome
Part A Treatment Emergent Adverse Events
Time frame: 7 days
Number of participants with Treatment Emergent Adverse Events
Part B: Treatment Emergent Adverse Events
Time frame: 14 days after last dose
Number of participants with Treatment Emergent Adverse Events
Part A: Clinically Significant Changes in Safety Tests
Time frame: 7 days
Number of participants with clinically significant changes in:vital signs (heart rate, blood pressure, respiratory rate, pulse oximetry and temperature), 12-lead electrocardiogram (ECG), Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), physical examination, nasal examination, laboratory safety tests (haematology, biochemistry and urinalysis), tolerability questionnaire
Part B:Clinically Significant Changes in Safety Tests
Time frame: 14 days after last dose
Number of participants with clinically significant changes in: vital signs (heart rate, blood pressure, respiratory rate, pulse oximetry and temperature), 12-lead electrocardiogram (ECG), FEV1, FVC, physical examination, nasal examination, laboratory safety tests (haematology, biochemistry and urinalysis), tolerability questionnaire
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.uk.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Neumifil in people with Viral Respiratory Tract Infection, 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 9 inclusion and 27 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 11 Jan 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 11 Jan 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?
Part A Treatment Emergent Adverse Events (time frame: 7 days). The study lists 4 primary outcomes in all. 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 11 Jan 2024.