ClinicalTrials.gg
Not yet recruitingNCT07898306Updated Oct 27, 2026

Nasal Residency of HEX17

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

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • HEX17
  • Antiviral
  • Intranasal Administration
  • FACS
  • Nasal Epithelium
  • Phase 1
  • Healthy Volunteers
  • Respiratory Viruses
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  1. Participants must have a written obtained prior to any study-related procedures.
  2. Participants must be able to understand and comply with the requirements of the study, as judged by the Investigator or delegate.
  3. Male and female participants aged between 18-55 years inclusive, at the time of informed consent.
  4. Female participants must either be:

    1. of non-,
    2. of childbearing potential who are not pregnant, breast feeding or lactating and use an approved method of highly effective method from either the time of informed consent (non-hormonal contraception) or at least 2 weeks prior to informed consent (hormonal contraception) and for 30 days following the last administered dose of IMP.
  5. Male participants who are sexually active with a partner of childbearing potential must use, with their partner, a male condom plus an approved method of highly effective contraception from the time of informed consent and for 30 days following their last administered dose of IMP.
  6. Participants must agree not to donate semen or ova/oocytes from the time of informed consent and for 30 days after the last dose of IMP.
  7. Participants must have a body weight of ≥50kg and (BMI) ≥ 18 kg/m2 and ≤ 29.9 kg/m2 at screening.
  8. Participants must be in good health as determined by medical history, concomitant medication use, physical examination, vital signs, 12-lead and clinical laboratory assessments at the time of screening and pre-dose Day 1 (as applicable) as judged by the Investigator or delegate.

Exclusion criteria

Exclusion Criteria:

  1. History or presence of any acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical study, expose the participant to undue risk or could interfere with the objectives of the study as judged by the Investigator or delegate.
  2. Significant history of seasonal allergies or chronic rhinosinusitis as judged by the Investigator or delegate.
  3. Any significant abnormality or piercing altering the anatomy of the nose or nasopharynx in a substantial way, including evidence of nasal inflammation, nasal polyps or known difficulties previously tolerating intranasal dosing that may prevent intranasal dosing on this study as judged by the Investigator or delegate.
  4. Significant history of epistaxis (large nosebleeds) or recurrent epistaxis prior to screening as judged by the Investigator or delegate and/or history of being hospitalised due to epistaxis on any previous occasion.
  5. Any nasal or sinus surgery within 3 months prior to screening.
  6. Any signs of respiratory tract infection within 4 weeks of screening or prior to dosing on Day 1 that is deemed clinically significant in the opinion of the Investigator or delegate.
  7. within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
  8. Any planned major surgery within the duration of the study or in the 30 days following study completion.
  9. Any other clinically significant illness, medical/surgical procedure or trauma within 6 weeks of screening or prior to the first administration of IMP (Day 1) as judged by the Investigator or delegate.
  10. Female participants with a positive urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) at screening or prior to dosing on Day 1.
  11. Positive serum surface antigen (HBsAg), virus antibodies (HCVAb) or (HIV) 1 and/or 2 antibodies at screening.
  12. History of any drug and/or alcohol abuse in the past 2 years prior to screening.
  13. The use of tobacco products, oral nicotine products, or e-cigarettes within 6 months prior to screening, or a cumulative smoking history equivalent of >5 pack-years. Nicotine replacement therapy (e.g., nicotine patches or gum) used for smoking cessation is permitted.
  14. Receiving any of the prohibited concomitant medications specified in Section 5.5.3 or any other concomitant medication that could interfere with the participant's safety during the clinical study, expose the participant to undue risk or could interfere with the objectives of the study as judged by the Investigator or delegate.
  15. Any changes to prescribed, chronic concomitant medications or commenced any new medications within 6 weeks of screening or prior to the first administration of IMP (Day 1).
  16. Plasma donation within one month of screening or blood donation (or corresponding blood loss) ≥400ml during the three months prior to screening.
  17. Participants who do not have suitable veins for multiple venepunctures as assessed by the Investigator or delegate at screen.
  18. Participant has dietary restrictions incompatible with the diet that can be provided by the study location, in the opinion of the Investigator or delegate, or is unwilling to refrain from consuming restricted foods and beverages during the study.
  19. Known history of intolerance or to HEX17 or to any other component of the formulation.
  20. Known history of intolerance to placebo or .
  21. Clinically significant serious adverse reaction, allergy or serious hypersensitivity, including to any drug or food, as judged by the Investigator or delegate.
  22. Involvement in the planning and conduct of the study.
  23. Participation in another clinical study with an experimental drug within 3 months (non-biologics), 6 months (biologics) or 5 half-lives, whichever is longer, before the administration of IMP.
  24. Considered unsuitable for entry into the study in any other way at the discretion of the Investigator or delegate, e.g. Investigator or delegate considers the participant unlikely to comply with study procedures, restrictions and requirements.
Terms in these criteria, in plain language(12)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    HEX17

    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

  • Placebo comparator
    Placebo

    Participants receive placebo intranasal spray administered according to the same schedule as the corresponding treatment group.

    Drug: Placebo

Interventions

  • DrugHEX17

    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.

  • DrugPlacebo

    Matching placebo liquid for intranasal spray administration used as a comparator control.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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).

  2. Change in Nasal Examination Findings

    Assessment of changes from baseline in nasal mucosal examination findings.

    Time frame: Up to Day 43

Other outcomes

  1. 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

  2. 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).

07

Study locations

1 site
  • Medicines Evaluation Unit, an IQVIA Business
    Manchester, Wythenshawe M23 9QZ, United Kingdom
    • Naimat Khan, M.D, MSc · Contactmkhan@meu.co.uk · 0161 9464050
    • Naimat Khan, M.D, MSc · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

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 ↗

10

Registry details

Key details

Study ID
NCT07898306
Lead sponsor
Pneumagen Ltd, a subsidiary of NorthLinks Bio
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Jan 21, 2027 (estimated)
Completion
Jan 25, 2027 (estimated)
Last update
Oct 27, 2026

Study contacts

Alexander Rumyantsev
Contact
arumyantsev@northlinksbio.com
+1 (240) 899-1304
Eve Billinge, MSc Pharm
Contact
ebillinge@crosolutions.co.uk
01618430906
Naimat Khan, M.D, MSc
principal investigator · Medicines Evaluation Unit, an IQVIA Business

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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