ClinicalTrials.gg
Not yet recruitingNCT07792928Updated Oct 13, 2026

A Study of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults

A Phase 1 interventional study of HCXT-2001 Tablets and Placebo in Psoriasis, sponsored by Shanghai Peptidstar Therapeutics Limited. Not yet recruiting at 3 sites in New Zealand. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Shanghai Peptidstar Therapeutics Limited · Phase 1, Interventional, and Treatment

Updated Oct 13, 2026Start date movedEligibility revised+2 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The goal of this intervention study is to assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Participants. The main parameters it aims to answer are: Does a single dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in healthy participants impact the Safety, Tolerability, Pharmacokinetics, and Immunogenicity profiles? This study will be a randomized, double blind, placebo-controlled study.

02

Conditions studied

  • Psoriasis

Browse trials for

03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 40 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

This is the only study on the registry with Shanghai Peptidstar Therapeutics Limited as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 13, 2026. See what changed

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Body weight ≥ 50 kg for males and ≥ 45 kg for females, and (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 , 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 .
  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 beginning at screening and continuing until 6 months after the last dose of the product and agree to voluntarily using one or more highly effective methods (Section 17) and no intention of donating sperm or eggs during this period.

Exclusion criteria

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 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 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), vaping (within 3 months prior to screening), or unwillingness to abstain from smoking/vaping 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: surface antigen, syphilis-specific antibody, antibody, or 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    HCXT-2001 Tablets - Cohort 1

    Drug: HCXT-2001 Tablets

  • Experimental
    HCXT-2001 Tablets - Cohort 2

    Drug: HCXT-2001 Tablets

  • Placebo comparator
    HCXT-2001 Tablets - Placebo Cohort 1

    Drug: Placebo

  • Experimental
    HCXT-2001 Tablets(A) - Cohort 3

    Drug: HCXT-2001 Tablets(A)

  • Experimental
    HCXT-2001 Tablets(A) - Cohort 4

    Drug: HCXT-2001 Tablets(A)

  • Placebo comparator
    HCXT-2001 Tablets(A) - Placebo Cohort 3

    Drug: Placebo

  • Placebo comparator
    HCXT-2001 Tablets - Placebo Cohort 2

    Drug: Placebo

  • Placebo comparator
    HCXT-2001 Tablets(A) - Placebo Cohort 4

    Drug: Placebo

Interventions

  • DrugHCXT-2001 Tablets

    Two tablets taken orally in a fasted state

  • DrugPlacebo

    Two tablets taken orally in a fasted state

  • DrugHCXT-2001 Tablets(A)

    Two tablets taken orally in a fasted state

  • DrugHCXT-2001 Tablets

    One tablet taken orally in a fasted state

  • DrugPlacebo

    One tablet taken orally in a fasted state

  • DrugHCXT-2001 Tablets(A)

    One tablet taken orally in a fasted state

06

What researchers measure

Primary outcomes

  1. Number of participants with AEs,SEAs, with abnormal - vital signs,physcial examinations,clinical laboratory results ,12-lead ECGs and stool routine tests

    Time frame: Day 1 to Day 50

Secondary outcomes

  1. Maximum concentration of the drug (Cmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).

    Will be calculated using the non-compartmental analysis.

    Time frame: Day 1 to Day 50

  2. Time to maximum concentration (Tmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).

    Will be calculated using the non-compartmental analysis.

    Time frame: Day 1 to Day 50

  3. Area under the plasma concentration-time curve (AUC, including AUC0-t and AUC0-inf, etc.) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).

    Will be calculated using the non-compartmental analysis.

    Time frame: Day 1 to Day 50

  4. Apparent volume of distribution (Vd/F) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).

    Will be calculated using the non-compartmental analysis.

    Time frame: Day 1 to Day 50

  5. Apparent clearance (CL/F) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A)

    Will be calculated using the non-compartmental analysis.

    Time frame: Day 1 to day 50

  6. Plasma elimination half-life (t1/2) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).

    Will be calculated using the non-compartmental analysis.

    Time frame: Day 1 to Day 50

  7. Mean residence time (MRT) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).

    Will be calculated using the non-compartmental analysis.

    Time frame: Day 1 to Day 50

  8. Anti-drug antibodies (ADAs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).

    Time frame: Day 1 to Day 50

  9. Neutralizing antibodies (Nabs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).

    Time frame: Day 1 to Day 50

07

Study locations

3 sites
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Nov 2026, 0 months later.

Of 137 industry-sponsored phase 1 interventional studies under Psoriasis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 0 months is below that.

Counting every sponsor, half of 155 studies reached it within 10 months; a quarter within 5 and three quarters within 17.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 13, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2026
First posted
Aug 28, 2026
StartEst.
Oct 14, 2026was Aug 2026
Primary completionEst.
Nov 10, 2026
CompletionEst.
Nov 10, 2026
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added
Show 2 added (2 New Zealand)
  • New Zealand Clinical Research Christchurch · Christchurch, New Zealand
  • New Zealand Clinical Research Auckland · Grafton, New Zealand
Oct 13, 2026
Start date
Aug 14, 2026→Oct 14, 2026
Oct 13, 2026
Eligibility
1 inclusion criterion edited; 1 exclusion criterion edited
What changed in the criteria
Inclusion criteria
  • EditedThe participant and their sexual partner(s) have no plans for conception from 2 weeks beforebeginning at screening and continuing 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 (Section 17) and no intention of donating sperm or eggs during this period.
Exclusion criteria
  • EditedHistory of smoking (average daily cigarette consumption ≥ 5 cigarettes within 3 months prior to screening), vaping (within 3 months prior to screening), or unwillingness to abstain from smoking/vaping during the study.
Oct 13, 2026
Title
A Phase 1 Study to Evaluate the Safety and Effects of a Single Dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults.
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    2 sites added
    Show 2 added (2 New Zealand)
    • New Zealand Clinical Research Christchurch · Christchurch, New Zealand
    • New Zealand Clinical Research Auckland · Grafton, New Zealand
    Start date Aug 14, 2026→Oct 14, 2026
    Eligibility 1 inclusion criterion edited; 1 exclusion criterion edited
    What changed in the criteria
    Inclusion criteria
    • EditedThe participant and their sexual partner(s) have no plans for conception from 2 weeks beforebeginning at screening and continuing 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 (Section 17) and no intention of donating sperm or eggs during this period.
    Exclusion criteria
    • EditedHistory of smoking (average daily cigarette consumption ≥ 5 cigarettes within 3 months prior to screening), vaping (within 3 months prior to screening), or unwillingness to abstain from smoking/vaping during the study.
    Title A Phase 1 Study to Evaluate the Safety and Effects of a Single Dose of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults.
    + 2 other changes: description and design details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07792928
Lead sponsor
Shanghai Peptidstar Therapeutics Limited
Collaborators
Emerald Clinical Trials Pty Ltd
Responsible party
Sponsor
First posted
Aug 28, 2026
Start date
Oct 14, 2026 (estimated)
Primary completion
Nov 10, 2026 (estimated)
Completion
Nov 10, 2026 (estimated)
Last update
Oct 13, 2026

Study contacts

Laura E Elliot, MBCHb
Contact
laura.elliott@momcr.co.nz
+64 9 242 3321

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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