Can a new pill tame psoriasis? early safety trial begins
NCT ID NCT07792928
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 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. 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.
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Pilot study to evaluate the effect of nicotinamide riboside on immune activation in psoriasis
- Can monthly selfies and symptom logs reveal how chronic skin diseases flare and settle?
- Can we predict the path of chronic skin disease?
- Can one pill tame four autoimmune diseases? a Long-Term trial puts it to the test
- Can a new skin ointment quiet psoriasis inflammation?
- Can a new gel calm psoriasis Flare-Ups?