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

Korábbi kezelés

• 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), 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.
• 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.

Más betegség

• History or presence of immunological diseases.
• Positive test result for any of the following: hepatitis B surface antigen, syphilis-specific antibody, hepatitis C antibody, or human immunodeficiency virus antibody.

Egyéb

• Women who are pregnant or are breastfeeding.
• 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.

• 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.