A Phase 1 interventional study of HEX17 and Placebo in Healthy Volunteers, sponsored by Pneumagen Ltd, a subsidiary of NorthLinks Bio. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Pneumagen Ltd, a subsidiary of NorthLinks Bio · Phase 1, Interventional, and Prevention
This Phase 1 study will evaluate HEX17, an investigational antiviral nasal spray, in healthy adult volunteers.
The study has two parts. Part A will validate a laboratory method called fluorescence activated cell sorting (FACS) to detect HEX17 bound to nasal epithelial cells after a single intranasal dose. Part B will investigate how long HEX17 remains present in nasal epithelial cells following five different dosing regimens.
The study will also assess the safety and tolerability of HEX17 following intranasal administration in healthy adult participants.
HEX17 is a first-in-class host-directed antiviral being developed as a broad-spectrum prophylactic antiviral medication against respiratory viruses. This study is designed to evaluate the presence and persistence of HEX17 in the nasal epithelium following intranasal administration.
This is a Phase 1, single-centre, randomised, single-blind, parallel-group study in healthy adult participants.
Part A will evaluate the use of FACS to detect HEX17 bound to nasal epithelial cells following a single intranasal administration of HEX17 or placebo. Four participants will be enrolled, with two participants receiving HEX17 and two participants receiving placebo.
Part B will commence after confirmation that HEX17 can be detected in nasal epithelial samples collected during Part A. Part B will enrol 40 healthy participants across five groups receiving different dosing regimens. Participants will receive HEX17 or placebo administered intranasally and will undergo nasal epithelial sampling, blood sampling and safety assessments.
The primary objectives are to validate detection of HEX17 bound to nasal epithelial cells and to assess the presence of HEX17 in nasal epithelium following different dosing regimens. Secondary objectives are to evaluate safety and tolerability. Exploratory objectives include evaluation of alternative analytical methods and assessment of the systemic presence or absence of HEX17 following intranasal administration.
This is the only study on the registry with Pneumagen Ltd, a subsidiary of NorthLinks Bio as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female participants must either be:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive intranasal HEX17. In Part A, participants receive a single 2.8 mg dose. In Part B, participants receive HEX17 according to one of five dosing regimens: single dose, daily, twice weekly, weekly or every two weeks.
Drug: HEX17
Participants receive placebo intranasal spray administered according to the same schedule as the corresponding treatment group.
Drug: Placebo
HEX17 liquid for intranasal spray administration. Participants receive a 2.8 mg dose administered as one actuation into each nostril. In Part A participants receive a single dose. In Part B participants receive HEX17 according to one of five dosing regimens: single dose, daily, twice weekly, weekly, or every two weeks.
Matching placebo liquid for intranasal spray administration used as a comparator control.
Detection of HEX17 Bound to Nasal Epithelial Cells (Part A)
Detection of HEX17 bound to nasal epithelial cells collected by nasal brushing and analysed using FACS.
Time frame: Up to Day 1
Presence of HEX17 in Nasal Epithelial Cells Following Different Dosing Regimens (Part B)
Assessment of the presence and persistence of HEX17 in nasal epithelial cells following intranasal administration using different dosing regimens.
Time frame: Up to Day 43
The number and Severity of Adverse Events
Assessment of the number, severity and relationship of adverse events following administration of HEX17 or placebo.
Time frame: Part A: From first dose on Day 1 until completion of follow-up assessments on Day 8 (up to 8 days). Part B: From first dose until completion of follow-up assessments after the final dose of IMP (up to 43 days).
Change in Nasal Examination Findings
Assessment of changes from baseline in nasal mucosal examination findings.
Time frame: Up to Day 43
Systemic Presence of HEX17 in Blood Measured by a Validated HEX17 Concentration Assay (Part B).
Presence or absence of HEX17 in blood collected at pre-dose and post-dose on the first and last dosing days.
Time frame: Up to Day 29
Detection and Quantification of HEX17 Associated With Nasal Epithelial Cells Using an Alternative Analytical Method
Presence or absence of HEX17 and, where feasible, amount of HEX17 associated with nasal epithelial cells collected by nasal brushing, measured by an analytical method other than FACS.
Time frame: From first dose until nasal epithelial sampling (up to Day 43).
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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