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.

NCT07792928 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: HCXT-2001-PS-1-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis

Outcome Measures

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

  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).

  Day 1 to Day 50

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

  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).

  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).

  Day 1 to Day 50

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

  Day 1 to day 50

Study Arms (8)

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

Interventions

HCXT-2001 Tablets DRUG

Two tablets taken orally in a fasted state

HCXT-2001 Tablets - Cohort 1

Placebo DRUG

Two tablets taken orally in a fasted state

HCXT-2001 Tablets - Placebo Cohort 1; HCXT-2001 Tablets(A) - Placebo Cohort 3

HCXT-2001 Tablets(A) DRUG

Two tablets taken orally in a fasted state

HCXT-2001 Tablets(A) - Cohort 3

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• 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.
• 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) or unwillingness to abstain from smoking 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.

Sponsors & Collaborators

• Shanghai Peptidstar Therapeutics Limited: lead
• Emerald Clinical Trials Pty Ltd: collaborator

Study Sites (1)

Momentum Clinical Research (MCR)

Takapuna, Auckland, 0622, New Zealand

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Laura E Elliot, MBCHb

CONTACT

+64 9 242 3321; laura.elliott@momcr.co.nz

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start: August 14, 2026
• Primary Completion (Estimated): November 10, 2026
• Study Completion (Estimated): November 10, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-07

Locations

NZ (1)