Psoriasis
Conditions
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.
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
Sponsors
Shanghai Peptidstar Therapeutics Limited
Emerald Clinical Trials Pty Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Will be calculated using the non-compartmental analysis. |
| Time to maximum concentration (Tmax) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A). | Day 1 to Day 50 | Will be calculated using the non-compartmental analysis. |
| 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 | Will be calculated using the non-compartmental analysis. |
| 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 | Will be calculated using the non-compartmental analysis. |
| Apparent clearance (CL/F) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A) | Day 1 to day 50 | Will be calculated using the non-compartmental analysis. |
| Plasma elimination half-life (t1/2) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A). | Day 1 to Day 50 | Will be calculated using the non-compartmental analysis. |
| Mean residence time (MRT) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A). | Day 1 to Day 50 | Will be calculated using the non-compartmental analysis. |
| Anti-drug antibodies (ADAs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A). | Day 1 to Day 50 | — |
| Neutralizing antibodies (Nabs) following a single oral dose of HCXT-2001 tablets and HCXT-2001 tablets(A). | Day 1 to Day 50 | — |
Countries
New Zealand
Contacts
CONTACTLaura E Elliot, MBCHb
Outcome results
None listed