Can a new oral drug tame psoriasis? early safety trial begins
NCT ID NCT07802964
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This Phase 1 trial tests a single oral dose of HRS-4139, an experimental drug for psoriasis, in healthy adults aged 18 to 55. Researchers measure how the body absorbs and processes the drug, and watch for any side effects. The goal is to establish a safe dose for future studies in people with psoriasis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-4139, an experimental oral tablet being developed as a potential treatment for psoriasis
- What this could lead to
- If this early trial shows the drug is safe and well tolerated, it could pave the way for larger studies to see whether HRS-4139 can help control psoriasis symptoms.
- What could go wrong
- This is a small, first-in-human study focused on safety, not effectiveness. The drug may not work as hoped, and side effects are possible.
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 40 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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Apr 2027
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 55 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 who understand the specific procedures of the trial, voluntarily agree to participate in this trial, and provide written informed consent. 2. Participants aged 18 to 55 years (inclusive) at screening. 3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) between 18.0 and 26.0 kg/m² (inclusive). 4. Participants who are able to communicate effectively with the investigator, fully understand and comply with all requirements of the trial protocol. Exclusion Criteria: 1. Participants with any disease of the circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems, or any other condition that may interfere with the trial results. 2. Participants with a history of malignancy. 3. Participants with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or with short QT syndrome or long QT syndrome, or with a family history in first-degree relatives of unexplained sudden death, drowning, or sudden infant death syndrome (SIDS) occurring at ≤ 40 years of age. 4. Participants who have had an opportunistic infection within 6 months prior to screening; or who have a known history of recurrent or chronic infections, or who have had chronic or recurrent sinusitis, tonsillitis, urinary tract infections, prostatitis, enteritis, etc. 5. Participants who have had an acute infection with systemic symptoms requiring systemic anti-infective therapy (intravenous or oral) within 4 weeks prior to screening. 6. Participants who have participated in any clinical trial of a drug or medical device within 3 months prior to screening, where participation is defined as having signed the informed consent and having received the investigational drug or medical device; or Participants who are still within the follow-up period of any clinical study or within 5 elimination half-lives of the study drug at the time of screening, whichever is longer. 7. Participants who have used any medication (including prescription drugs, over-the-counter medications, Chinese herbal medicines, dietary supplements, etc.) within 2 weeks or within 5 elimination half-lives (whichever is longer) prior to the administration of the study drug; or Participants who plan to use any other medication during the study period. 8. Participants who have received a live (attenuated) vaccine within 1 month prior to screening or plan to receive such a vaccine during the trial period, with the exception of influenza vaccination. 9. Participants who have experienced severe trauma or undergone major surgery within 6 months prior to screening, or who plan to undergo surgery during the trial period. 10. Participants who have donated blood or experienced significant blood loss (≥ 400 mL) within 1 month prior to screening, or who have received a blood transfusion within 2 months prior to screening.
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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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Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Small study to uncover how psoriasis drug tames the immune system
- Psoriasis drug trial aims to calm overactive immune cells
- Diabetes drug cream shows promise for psoriasis in new trial
- Blood test may end guesswork in psoriasis dosing
- New study to measure psoriasis treatment success beyond the skin