Phase 1 Study to Assess the Effects of HSK31858 on the QT/QTc Interval in Healthy Chinese Participants

Laborértékek

• 1) During the screening period or baseline period, if the results of vital signs, physical examination, laboratory tests (blood cell analysis (five-category), blood biochemistry, coagulation function, urine routine test plus sediment), frontal or lateral chest X-rays or CT, ultrasound examination, etc. are abnormal and of clinical significance, or if physical examination reveals tattoos or scars on any part of the skin that affect safety evaluation;
  • Abnormal electrocardiogram (ECG) results during the screening period or baseline period with clinical significance, or QTcF\> 450ms;
  • Those who test positive for any one of the following: hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or Treponema pallidum antibody during the screening period;
  • Those who are known to be allergic to any component of HSK31858 Tablets, moxifloxacin hydrochloride tablets or similar drugs and their preparations, or those with an allergic constitution (such as allergic to two or more substances); Or those with a specific history of allergies (such as asthma, urticaria, eczema, etc.);
  • There is a history of any type of cardiovascular disease/disorder/surgery that may increase the possibility of prolonged QT interval or other risk factors for torus pointes ventricular tachycardia (such as heart failure, hypokalemia, hypomagnemia, congenital long QT syndrome or a family history of long QT syndrome, etc.);
  • Those who have had or are currently suffering from periodontitis, palmoplantar hyperkeratosis, or major/chronic diseases of the cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune, skin, nervous systems, etc., or have any other diseases during the screening period;
  • Those who have donated blood or lost blood of ≥400 mL within 3 months prior to screening, or have donated blood during the planned study period, or have received blood transfusion or used blood products within 3 months prior to screening;
  • Those who have previously undergone diseases or surgeries that could interfere with drug absorption, distribution, metabolism or excretion (such as gastrointestinal resection), or those who have undergone major surgeries within 3 months prior to the screening period or whose surgical incisions have not fully healed;
  • Any drugs that inhibit or induce liver CYP enzymes (such as CYP3A4 inducers - rifampicin, dexamethasone, carbamazepine, oxcarbazepine, phenytoin, phenytoin, deoxyphenybital, enzalutamide, St. John's wort, etc.) have been used within 28 days before screening or within 5 half-lives of the drugs (whichever is longer). CYP3A4 inhibitors such as itraconazole, ketoconazole, voriconazole, erythromycin, clarithromycin, ritonavir, etc., or any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health supplements other than the above-mentioned drugs have been taken within 14 days before screening or within 5 half-lives (whichever is longer) of the drug.
  • Those who have participated in other drug clinical trials and used the investigational drug within 3 months prior to screening, or are still within the follow-up period of a certain clinical trial or within 5 half-lives of the investigational drug before screening (whichever is longer); Or those who plan to participate in other clinical trials during the trial period;
  • Those who have received a live vaccine (except for the influenza vaccine) within one month before screening or plan to receive a live vaccine during the trial period;
  • Those with a history of drug abuse, drug abuse or drug dependence, or with a positive screening result for drug abuse;
  • Those who frequently consumed alcohol within the three months prior to screening, that is, those who consumed more than 14 units of alcohol per week (1 unit =360mL of beer or 45mL of 40% alcohol spirit or 150 ml of wine), or those who were unable to ablate alcohol during the test period, or those with a positive breath test for alcohol;
  • The average daily smoking (or the use of an equivalent amount of nicotine-containing products) in the three months prior to screening was more than five cigarettes, or smoking was not allowed during the trial period;
  • Those who have consumed excessive amounts of tea, coffee or caffeinated beverages (an average of more than 4 cups per day, 1 cup =250mL) within the three months prior to screening; Or those who have consumed tea or any food or beverage containing caffeine (such as coffee, chocolate, etc.) within 48 hours before the first administration; Or disagree to stop taking tea, coffee or foods or beverages containing caffeine during the trial period;
  • Those who have consumed a large amount of beverages or foods rich in grapefruit (such as grapefruit, grapefruit juice, grapefruit jam, etc.) within 14 days before screening; Or those who have consumed any beverage or food rich in grapefruit (i.e. grapefruit) within 48 hours before the first administration; Or those who do not agree to stop drinking any beverages or foods rich in grapefruit (i.e. grapefruit) during the trial period;
  • Those with a history of difficulty in venous blood collection, fainting at the sight of needles or blood, or those with poor venous assessment or inability to tolerate venous puncture blood collection;
  • Those who have special dietary requirements and cannot follow a uniform diet; Or those who have difficulty swallowing;
  • Pregnant or lactating women, or those whose pregnancy test results exceed the upper limit of the normal value, or female participants who engaged in non-protective sexual behavior two weeks before screening;
  • Participants who the researchers consider to have poor compliance or other factors that make them unsuitable for participating in this trial.

• At the time of screening, the age should be between 18 and 45 years old (including the boundary value), and healthy male or female.
• When screening, the weight of men should be ≥50kg and that of women ≥45kg. And the body mass index (BMI= weight (kg)/height (m2)) is within the range of 19.0 to 26.0 kg/m2 (including the boundary value);
• Participants (including their partners) had no plans for having children or donating sperm or eggs during the trial period and within 3 months after the last administration, and agreed to take effective contraceptive measures (for details, see Appendix 1);
• Fully understand the purpose, requirements and possible risks of this trial, voluntarily participate in the clinical trial and be able to sign the informed consent form before the trial commences