Can a new injection calm severe eczema?
NCT ID NCT07801612
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, 310006, China
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