Can a new injection calm severe eczema?

NCT ID NCT07801612

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental drug called HXN5003 in healthy volunteers and in people with moderate-to-severe atopic dermatitis, a common form of eczema. The study first gives a single dose to healthy participants to check safety, then gives multiple doses to eczema patients to see how the drug behaves and whether it shows any sign of easing the condition. Researchers are looking mainly at side effects and how the body processes the drug, with effectiveness as a secondary goal.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HXN5003, an experimental drug given as an injection under the skin
What this could lead to
If HXN5003 proves safe and shows promise, it could become a new treatment option for people with moderate-to-severe atopic dermatitis, helping to control the condition.
What could go wrong
This is an early Phase 1 trial with a small number of participants, so the drug may not work as hoped or may cause side effects. The results will only show initial safety and hints of effectiveness, not a proven treatment.

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 68 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

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 70 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 be able to understand and comply with the study requirements and voluntarily sign the informed consent form (ICF). 2. (Healthy Participants) Male or female participants aged 18 to 50 years (inclusive) at the time of signing the ICF. 3. (Healthy Participants) Male participants weighing ≥ 50.0 kg and female participants weighing ≥ 45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m² (inclusive). 4. (Patients with AD) Male or female participants aged 18 to 70 years (inclusive) 5. (Patients with AD) Participants must have documented AD history, moderate-to-severe disease, and inadequate response to topical therapy at screening. Exclusion Criteria: 1. Presence of any clinically significant disease at randomization, as judged by the investigator. 2. History of severe drug allergy or systemic anaphylactic reactions, such as anaphylactic shock, laryngeal edema, etc. 3. Known or suspected history of immunosuppression, or history of invasive opportunistic infections, including infections that are unusually frequent, recurrent, or prolonged in duration as judged by the investigator, even after resolution of the infection. 4. Participants who have resided long-term in regions with high prevalence of Human Herpesvirus-8 (HHV-8), such as Africa or the Mediterranean coastal areas. 5. History of malignancy or malignant disease, with the exception of surgically excised cutaneous squamous cell carcinoma in situ, basal cell carcinoma, and cervical carcinoma in situ that have been in complete remission for more than 5 years without any evidence of recurrence. 6. Female participants who are breastfeeding or pregnant, or women of childbearing potential with a positive serum pregnancy test result at screening. 7. Participants with a chronic active infection or a condition that would seriously interfere with study drug administration at baseline within 4 weeks prior to randomization; or a superficial skin infection requiring treatment within 1 week prior to randomization; or an acute illness within 48 hours prior to randomization. 8. (Patients with AD) Other than AD, A history of clinically significant disease which is poorly controlled or could pose a safety risk to the participant or confound the safety assessment, as judged by the Investigator to compromise participant safety in the study. 9. (Patients with AD) Positive results in any of the following infectious disease screening tests: 1)History of active tuberculosis, or positive result at screening (T-SPOT.TB or QuantiFERON-TB Gold); 2)Positive for hepatitis B; 3)Positive hepatitis C antibody; 4)Positive Treponema pallidum antibody; 5)History of HIV infection, or positive HIV antibody.

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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

  • Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University

    Hangzhou, Zhejiang, 310006, China

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