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.
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.
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.
Single group
HCXT-2001 Tablets
DrugTwo tablets taken orally in a fasted state
Placebo
DrugTwo tablets taken orally in a fasted state
HCXT-2001 Tablets(A)
DrugTwo tablets taken orally in a fasted state
HCXT-2001 Tablets
DrugOne tablet taken orally in a fasted state
Placebo
DrugOne tablet taken orally in a fasted state
HCXT-2001 Tablets(A)
DrugOne tablet taken orally in a fasted state
8
Treatment groupsSee each treatment group below.
Number of participants with AEs,SEAs, with abnormal - vital signs,physcial examinations,clinical laboratory results ,12-lead ECGs and stool routine tests
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 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.
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.
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.
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Shanghai Peptidstar Therapeutics Limited
Lead sponsor
Emerald Clinical Trials Pty Ltd
Collaborator
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