Healthy VolunteersPhase 1NCT07898306
Nasal Residency of HEX17
A Phase 1 study testing HEX17 in people with Healthy Volunteers, run by Pneumagen Ltd, a subsidiary of NorthLinks Bio at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- HEX17
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2026to 25 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants must have a written informed consent obtained prior to any study-related procedures.
- Participants must be able to understand and comply with the requirements of the study, as judged by the Investigator or delegate.
- Male and female participants aged between 18-55 years inclusive, at the time of informed consent.
- Female participants must either be:
- of non-childbearing potential,
- of childbearing potential who are not pregnant, breast feeding or lactating and use an approved method of highly effective birth control 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.
Show all 10Show fewer
- 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.
- 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.
- Participants must have a body weight of ≥50kg and body mass index (BMI) ≥ 18 kg/m2 and ≤ 29.9 kg/m2 at screening.
- Participants must be in good health as determined by medical history, concomitant medication use, physical examination, vital signs, 12-lead ECG and clinical laboratory assessments at the time of screening and pre-dose Day 1 (as applicable) as judged by the Investigator or delegate.
Who cannot join
- History or presence of any clinically relevant 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.
- Significant history of seasonal allergies or chronic rhinosinusitis as judged by the Investigator or delegate.
- 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.
- 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.
- Any nasal or sinus surgery within 3 months prior to screening.
- 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.
Show all 24Show fewer
- Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.
- Any planned major surgery within the duration of the study or in the 30 days following study completion.
- 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.
- 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.
- Positive serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or 2 antibodies at screening.
- History of any drug and/or alcohol abuse in the past 2 years prior to screening.
- 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.
- 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.
- 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).
- Plasma donation within one month of screening or blood donation (or corresponding blood loss) ≥400ml during the three months prior to screening.
- Participants who do not have suitable veins for multiple venepunctures as assessed by the Investigator or delegate at screen.
- 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.
- Known history of intolerance or hypersensitivity to HEX17 or to any other component of the formulation.
- Known history of intolerance to placebo or excipients.
- Clinically significant serious adverse reaction, allergy or serious hypersensitivity, including to any drug or food, as judged by the Investigator or delegate.
- Involvement in the planning and conduct of the study.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Medicines Evaluation Unit, an IQVIA Business
Manchester, Wythenshawe, M23 9QZ
Naimat Khan, M.D, MSc, 0161 9464050, mkhan@meu.co.uk
Naimat Khan, M.D, MSc
About this study
Official title: A Two-part, Single Blind, Parallel Group, Phase 1 Study to Validate the Use of Fluorescence Activated Cell Sorting (FACS) Assay to Detect HEX17 Bound to Nasal Epithelial Cells (Part A) and to Investigate the Nasal Residence of HEX17 Using Five Dosing Regimens in Healthy Adult Participants (Part B).
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.
- Conditions
- Healthy Volunteers
- Being tested
- HEX17, Placebo
- Keywords
- HEX17, Antiviral, Intranasal Administration, FACS, Nasal Epithelium, Phase 1, Healthy Volunteers, Respiratory Viruses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEX17Drug
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.
PlaceboDrug
Matching placebo liquid for intranasal spray administration used as a comparator control.
| Study group | Role | What they receive |
|---|---|---|
| HEX17 | Experimental | 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. Receives: Drug: HEX17 |
| Placebo | Placebo comparator | Participants receive placebo intranasal spray administered according to the same schedule as the corresponding treatment group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to Day 43
Secondary outcomes (2)
The number and Severity of Adverse Events
Assessment of the number, severity and relationship of adverse events following administration of HEX17 or placebo.
Measured: 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.
Measured: Up to Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion21 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pneumagen Ltd, a subsidiary of NorthLinks Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Naimat Khan, M.D, MSc, Principal investigator, Medicines Evaluation Unit, an IQVIA Business
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898306
- Sponsor's protocol ID
- PNG-NMF-102
- Other IDs
- CROS063, MEU 24-472
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-part, Single Blind, Parallel Group, Phase 1 Study to Validate the Use of Fluorescence Activated Cell Sorting (FACS) Assay to Detect HEX17 Bound to Nasal Epithelial Cells (Part A) and to Investigate the Nasal Residence of HEX17 Using Five Dosing Regimens in Healthy Adult Participants (Part B).
- ClinicalTrials.gov ID
- NCT07898306
- Acronym / sponsor ID
- PNG-NMF-102
- Conditions
- Healthy Volunteers
- Keywords
- HEX17, Antiviral, Intranasal Administration, FACS, Nasal Epithelium, Phase 1, Healthy Volunteers, Respiratory Viruses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Pneumagen Ltd, a subsidiary of NorthLinks BioIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2026 (estimated)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 27 Oct 2026 (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 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HEX17 | Experimental | Drug: HEX17Participants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo intranasal spray administered according to the same schedule as the corresponding treatment group. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Participants must have a written informed consent obtained prior to any study-related procedures.
- Participants must be able to understand and comply with the requirements of the study, as judged by the Investigator or delegate.
- Male and female participants aged between 18-55 years inclusive, at the time of informed consent.
- Female participants must either be:
- 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.
Key exclusion criteria (24 listed)
- History or presence of any clinically relevant 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.
- Significant history of seasonal allergies or chronic rhinosinusitis as judged by the Investigator or delegate.
- 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.
- 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.
- Any nasal or sinus surgery within 3 months prior to screening.
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 |
|---|---|---|
| HEX17HEX17 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. | Drug | HEX17 |
| PlaceboMatching placebo liquid for intranasal spray administration used as a comparator control. | Drug | Placebo |
Primary outcome
Detection of HEX17 Bound to Nasal Epithelial Cells (Part A)
Time frame: Up to Day 1
Detection of HEX17 bound to nasal epithelial cells collected by nasal brushing and analysed using FACS.
Presence of HEX17 in Nasal Epithelial Cells Following Different Dosing Regimens (Part B)
Time frame: Up to Day 43
Assessment of the presence and persistence of HEX17 in nasal epithelial cells following intranasal administration using different dosing regimens.
2 secondary outcomes
The number and Severity of Adverse Events
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
Time frame: Up to Day 43
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
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.
Naimat Khan, M.D, MSc principal investigator
Medicines Evaluation Unit, an IQVIA Business
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 HEX17 in people with Healthy Volunteers, run by Pneumagen Ltd, a subsidiary of NorthLinks Bio 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 10 inclusion and 24 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Rumyantsev (+1 (240) 899-1304, arumyantsev@northlinksbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of HEX17 Bound to Nasal Epithelial Cells (Part A) (time frame: Up to Day 1). 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?
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 27 Oct 2026.