Can a new pill tame psoriasis? early safety trial begins

NCT ID NCT07792928

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This early-stage trial tests an experimental oral drug called HCXT-2001 in healthy adults to see if it is safe and how the body handles it. Researchers give a single dose of the drug or a placebo and monitor for side effects, vital signs, and lab results. The study also measures how much of the drug reaches the bloodstream and how long it stays there. Success here would pave the way for testing the drug 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
HCXT-2001 tablets, an experimental oral drug for psoriasis
What this could lead to
If safe and well-tolerated, HCXT-2001 could become a new oral option for managing psoriasis, offering an alternative to current treatments.
What could go wrong
This is an early phase 1 study in healthy volunteers, not people with psoriasis. The drug may not prove effective or may show side effects in later trials.

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 40 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

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 45 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. Body weight ≥ 50 kg for males and ≥ 45 kg for females, and body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening. 2. In good general health as determined by medical history, vital signs, physical examination, 12-lead ECG, laboratory tests (including hematology, blood biochemistry, coagulation function tests, urinalysis, stool routine tests), chest X-ray, etc., with results either within normal limits or assessed by the investigator as not clinically significant. 3. Has been fully informed about the study, voluntarily agrees to participate, and has signed the ICF. 4. The participant and their sexual partner(s) have no plans for conception from 2 weeks before screening until 6 months after the last dose of the investigational product, and agree to voluntarily using one or more highly effective non-pharmacological contraceptive methods and no intention of donating sperm or eggs during this period. Exclusion Criteria: 1. History or presence of immunological diseases. 2. Women who are pregnant or are breastfeeding. 3. Any prior or current disease or abnormality that, in the investigator's judgment, is clinically significant and may interfere with the conduct or interpretation of the study, including but not limited to neurological, cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, oncologic, pulmonary, immunological, psychiatric, or cerebrovascular conditions. 4. Individuals who smoked, consumed coffee, St. John's Wort (hypericum perforatum), grapefruit, pomelo juice, or cranberry juice, and/or engagement in strenuous physical activity within 24 hours prior to dosing, which in the opinion of the investigator may affect drug absorption, distribution, metabolism, or excretion. 5. Suspected or known allergy to any component of the investigational product, or any documented history of allergies 6. Previous surgical procedures that may affect the results of the clinical study or gastric/abdominal surgery that may impact oral drug absorption; or recent major gastric/abdominal surgery of any kind within 12 weeks prior to screening or during study. With the exception of minor surgeries that in the opinion of the investigator/medical monitor, such as excision of subcutaneous lipomas. 7. Having taken any prescription medication, over-the-counter drug, herbal medicine, or dietary supplement within 14 days prior to dosing or within five half-lives of the first administration, except for the condition without impact on the study outcomes as determined by the investigator. Occasional paracetamol less than 1000 mg for minor ailments is permitted if required. 8. Non-physiological blood loss or donation of more than 400 mL of blood within 2 months prior to screening, receipt of a blood transfusion within 2 months prior to screening; or plans to donate blood during the study or within 60 days after the last dose. 9. Participation in any investigational drug or medical device clinical trial with administration of the investigational product or device intervention within 3 months or five half-lives prior to screening. 10. History of alcohol abuse, or consumption of more than 14 alcohol units per week within 6 months prior to screening , or unwillingness to abstain from alcohol during the study, or a positive alcohol test at screening. 11. History of smoking (average daily cigarette consumption ≥ 5 cigarettes within 3 months prior to screening) or unwillingness to abstain from smoking during the study. 12. History of drug abuse, use of illicit drugs within 3 months prior to the study, or a positive urine drug screen. 13. Infection (including chronic or localized infection) within 7 days prior to screening, or a history of recurrent infections with underlying conditions predisposing to infections, or a history of opportunistic infections. 14. Positive test result for any of the following: hepatitis B surface antigen, syphilis-specific antibody, hepatitis C antibody, or human immunodeficiency virus antibody. 15. Those who have received any vaccine within 1 month prior to screening, or who are scheduled to receive any vaccine during the study or within 1 month after study completion. 16. Having any other factors that, in the opinion of the investigator, may affect the study results or interfere with the participant's participation in the clinical study.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Psoriasis are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • Momentum Clinical Research (MCR)

    Takapuna, Auckland, 0622, New Zealand

More trials for these conditions

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