PsoriasisPhase 1NCT07792928
A Study of HCXT-2001 Tablets and HCXT-2001 Tablets(A) in Healthy Adults
A Phase 1 study testing HCXT-2001 Tablets and HCXT-2001 Tablets(A) in people with Psoriasis, run by Shanghai Peptidstar Therapeutics Limited at 3 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- HCXT-2001 Tablets and HCXT-2001 Tablets(A)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesNew Zealand
- Study dates
- 14 Oct 2026to 10 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
- Has been fully informed about the study, voluntarily agrees to participate, and has signed the ICF.
- 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 investigational product and agree to voluntarily using one or more highly effective contraceptive methods (Section 17) and no intention of donating sperm or eggs during this period.
Who cannot join
- History or presence of immunological diseases.
- Women who are pregnant or are breastfeeding.
- 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.
- 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.
- Suspected or known allergy to any component of the investigational product, or any documented history of allergies
- 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.
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- 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.
- 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.
- 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.
- 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.
- 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.
- History of drug abuse, use of illicit drugs within 3 months prior to the study, or a positive urine drug screen.
- 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.
- Positive test result for any of the following: hepatitis B surface antigen, syphilis-specific antibody, hepatitis C antibody, or human immunodeficiency virus antibody.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand3 sites
New Zealand Clinical Research Christchurch
Christchurch
Dr Kody Shaw, +640800862278, Kody.shaw@nzcr.co.nz
New Zealand Clinical Research Auckland
Grafton
Dr Christian Schwabe, +648007883437, Christian.schwabe@nzcr.co.nz
Momentum Clinical Research (MCR)
Takapuna, Auckland, 0622
Laura E Elliot, MBCHb, +64 9 242 3321, laura.elliott@momcr.co.nz
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HCXT-2001 Tablets and HCXT-2001 Tablets(A) After Single Administration in Healthy Adult Participants.
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.
- Conditions
- Psoriasis
- Being tested
- HCXT-2001 Tablets, Placebo, HCXT-2001 Tablets(A)
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCXT-2001 TabletsDrug
Two tablets taken orally in a fasted state
PlaceboDrug
Two tablets taken orally in a fasted state
HCXT-2001 Tablets(A)Drug
Two tablets taken orally in a fasted state
HCXT-2001 TabletsDrug
One tablet taken orally in a fasted state
PlaceboDrug
One tablet taken orally in a fasted state
HCXT-2001 Tablets(A)Drug
One tablet taken orally in a fasted state
| Study group | Role | What they receive |
|---|---|---|
| HCXT-2001 Tablets - Cohort 1 | Experimental | Not described Receives: Drug: HCXT-2001 Tablets |
| HCXT-2001 Tablets - Cohort 2 | Experimental | Not described Receives: Drug: HCXT-2001 Tablets |
| HCXT-2001 Tablets - Placebo Cohort 1 | Placebo comparator | Not described Receives: Drug: Placebo |
| HCXT-2001 Tablets(A) - Cohort 3 | Experimental | Not described Receives: Drug: HCXT-2001 Tablets(A) |
| HCXT-2001 Tablets(A) - Cohort 4 | Experimental | Not described Receives: Drug: HCXT-2001 Tablets(A) |
| HCXT-2001 Tablets(A) - Placebo Cohort 3 | Placebo comparator | Not described Receives: Drug: Placebo |
| HCXT-2001 Tablets - Placebo Cohort 2 | Placebo comparator | Not described Receives: Drug: Placebo |
| HCXT-2001 Tablets(A) - Placebo Cohort 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with AEs,SEAs, with abnormal - vital signs,physcial examinations,clinical laboratory results ,12-lead ECGs and stool routine tests
Measured: Day 1 to Day 50
Secondary outcomes (9)
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.
Measured: Day 1 to Day 50
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.
Measured: Day 1 to Day 50
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.
Measured: Day 1 to Day 50
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.
Measured: Day 1 to Day 50
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.
Measured: Day 1 to day 50
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.
Measured: Day 1 to Day 50
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.
Measured: Day 1 to Day 50
Anti-drug antibodies (ADAs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Measured: Day 1 to Day 50
Neutralizing antibodies (Nabs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Measured: Day 1 to Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start14 Oct 2026 (estimated)
- Primary completion10 Nov 2026 (estimated)
- Study completion10 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Peptidstar Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Emerald Clinical Trials Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792928
- Sponsor's protocol ID
- HCXT-2001-PS-1-02
- Status last verified
- Jul 2026
- First submitted
- 25 Aug 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HCXT-2001 Tablets and HCXT-2001 Tablets(A) After Single Administration in Healthy Adult Participants.
- ClinicalTrials.gov ID
- NCT07792928
- Acronym / sponsor ID
- HCXT-2001-PS-1-02
- Conditions
- Psoriasis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Peptidstar Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Emerald Clinical Trials Pty Ltd
- Study start
- 14 Oct 2026 (estimated)
- Primary completion
- 10 Nov 2026 (estimated)
- Study completion
- 10 Nov 2026 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HCXT-2001 Tablets - Cohort 1 | Experimental | Drug: HCXT-2001 Tablets |
| HCXT-2001 Tablets - Cohort 2 | Experimental | Drug: HCXT-2001 Tablets |
| HCXT-2001 Tablets - Placebo Cohort 1 | Placebo comparator | Drug: Placebo |
| HCXT-2001 Tablets(A) - Cohort 3 | Experimental | Drug: HCXT-2001 Tablets(A) |
| HCXT-2001 Tablets(A) - Cohort 4 | Experimental | Drug: HCXT-2001 Tablets(A) |
| HCXT-2001 Tablets(A) - Placebo Cohort 3 | Placebo comparator | Drug: Placebo |
| HCXT-2001 Tablets - Placebo Cohort 2 | Placebo comparator | Drug: Placebo |
| HCXT-2001 Tablets(A) - Placebo Cohort 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- 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.
- Has been fully informed about the study, voluntarily agrees to participate, and has signed the ICF.
- 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 investigational product and agree to voluntarily using one or more highly effective contraceptive methods (Section 17) and no intention of donating sperm or eggs during this period.
Key exclusion criteria (16 listed)
- History or presence of immunological diseases.
- Women who are pregnant or are breastfeeding.
- 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.
- 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.
- Suspected or known allergy to any component of the investigational product, or any documented history of allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCXT-2001 TabletsTwo tablets taken orally in a fasted state | Drug | HCXT-2001 Tablets - Cohort 1 |
| PlaceboTwo tablets taken orally in a fasted state | Drug | HCXT-2001 Tablets - Placebo Cohort 1, HCXT-2001 Tablets(A) - Placebo Cohort 3 |
| HCXT-2001 Tablets(A)Two tablets taken orally in a fasted state | Drug | HCXT-2001 Tablets(A) - Cohort 3 |
| HCXT-2001 TabletsOne tablet taken orally in a fasted state | Drug | HCXT-2001 Tablets - Cohort 2 |
| PlaceboOne tablet taken orally in a fasted state | Drug | HCXT-2001 Tablets - Placebo Cohort 2, HCXT-2001 Tablets(A) - Placebo Cohort 4 |
| HCXT-2001 Tablets(A)One tablet taken orally in a fasted state | Drug | HCXT-2001 Tablets(A) - Cohort 4 |
Primary outcome
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
9 secondary outcomes
Maximum concentration of the drug (Cmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Time frame: Day 1 to Day 50
Time to maximum concentration (Tmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Time frame: Day 1 to Day 50
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).
Time frame: Day 1 to Day 50
Apparent volume of distribution (Vd/F) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Time frame: Day 1 to Day 50
Apparent clearance (CL/F) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A)
Time frame: Day 1 to day 50
Plasma elimination half-life (t1/2) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Time frame: Day 1 to Day 50
Mean residence time (MRT) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Time frame: Day 1 to Day 50
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
Neutralizing antibodies (Nabs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A).
Time frame: Day 1 to Day 50
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HCXT-2001 Tablets and HCXT-2001 Tablets(A) in people with Psoriasis, run by Shanghai Peptidstar Therapeutics Limited at 3 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura E Elliot, MBCHb (+64 9 242 3321, laura.elliott@momcr.co.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.