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New eczema drug HXN5003 enters first human safety trial

NCT ID NCT07549750

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called HXN5003 in 28 healthy adults to see if it is safe and how the body processes it. The drug is being developed for atopic dermatitis (eczema). Participants receive either the drug or a placebo, and researchers monitor for side effects and measure drug levels in the blood.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 28 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants must sign an Institutional Review Board (IRB) approved informed consent form before any study specific procedure. 2. Male and female participants aged between 18 to 55 years, inclusive. 3. Participants must have a body mass index between 18 to 32 kg/m2, inclusive. 4. Able to participate and comply with all study procedures and restrictions 5. Participants must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers. Exclusion Criteria: 1. Females who are pregnant, planning to become pregnant, or lactating during the trial. 2. Participant who has history or evidence of any active or suspected infection within the past 14 days prior to randomization; 3. Participant who has known positive tuberculin skin test or recent exposure to an individual with active tuberculosis (TB), or current clinical or laboratory evidence of active TB. 4. Participant who has history of malignancy within 5 years before randomization, excluding localized basal cell carcinoma or cutaneous squamous cell carcinoma of the skin that have been resected or cured.. 5. Participant who has known type I/II diabetes. 6. Positive for human immunodeficiency virus (HIV) antibodies, syphilis test, hepatitis B surface antigen, or hepatitis C antibodies. 7. Participant who has tested positive for drugs use at Screening or before randomization; 8. Participant who has used nicotine or tobacco containing products within 3 months (\>5 cigarettes or an equivalent amount of tobacco per day) 9. Participant who has a history of alcohol abuse (alcohol consumption in excess of 14 units per week 10. Participant who has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives prior to dosing, or plan to receive another experimental agent during the duration of this trial; 11. Participants who have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing. 12. Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing; 13. Recent exposure to live vaccines within 30 days, or non-live vaccines (including mRNA COVID/flu) within 2 weeks prior to randomization, 14. Participants with herpes zoster reactivation or cytomegalovirus (CMV) that resolved less than 60 days prior to signing informed consent. 15. Abnormal renal function estimated glomerular filtration rate calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \< 70mL/min/1.73m2 16. Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results 17. Participant who has clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months prior to randomization, or plan to have any surgeries during the duration the trial; 18. History of any severe hypersensitivity or allergic reaction (i.e. anaphylaxis or angioedema) to any drug; 19. History of, or current, clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurologic, psychiatric, immunologic, Gilbert's Syndrome and allergic disease or any other condition, in the opinion of the Investigator, might interfere with the absorption, distribution, metabolism, or excretion of study drug; or place the participant at risk in this study or interfere with the interpretation of data. 20. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Veritus Research

    Bayswater, Victoria, 3153, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.