A Phase Ia Study of KMY Tablets in Healthy Subjects

This is a single-center, Phase Ia, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of KMY Tablets in healthy subjects. The study consists of three parts: a Single-Ascending Dose part, a Multiple-Ascending Dose part, and a Food-Effect part. A total of 120 subjects will be enrolled. The primary objectives are to assess the safety and tolerability profile and to investigate the effect of food on pharmacokinetics. Secondary objectives include characterizing the single- and multiple-dose pharmacokinetic profiles and investigating the metabolism and excretion of KMY Tablets

Inclusion criteria

• Healthy male or female participants aged 18 to 45 years (inclusive).
• Male participants weigh ≥50.0 kg; female participants weigh ≥45.0 kg. Body Mass Index (BMI) is between 19.0 and 26.0 kg/m² (inclusive).
• Participants agree to use effective contraception from screening until a specified period after the last dose and have no plan for pregnancy, sperm donation, or egg donation.
• Voluntarily participate in the trial, fully understand the study, sign the informed consent form, and are able to comply with the study procedures.

Exclusion criteria

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• Known history of allergy to the active ingredient, excipients of the investigational drug, or related compounds; or allergic constitution (e.g., allergy to two or more drugs or foods).
• History or presence of severe chronic diseases of the cardiovascular, hepatic, renal, respiratory, hematological, endocrine, immune, psychiatric, or neurological systems within the past year, which in the investigator's judgment may compromise participant safety or study integrity.
• Abnormal and clinically significant findings in vital signs, physical examination, laboratory tests (hematology, blood chemistry, urinalysis, coagulation), or 12-lead ECG at screening, as judged by the investigator.
• Use of any medications (including prescription, over-the-counter, or herbal medicines) or health supplements within a specified period (e.g., 2 weeks) prior to screening.
• Participation in another clinical trial (drug or medical device) or use of any other investigational drug within a specified period (e.g., 3 months) prior to screening.
• History of drug abuse or positive urine drug screen.
• Donation or loss of ≥400 mL of blood, or receipt of blood products, within a specified period (e.g., 6 months) prior to screening.
• History of alcohol abuse, inability to abstain from alcohol during the study, or positive alcohol breath test.
• Smoking more than a specified number of cigarettes per day (e.g., 5) within a specified period prior to screening, or inability to cease use of tobacco products during the study.
• Intolerance to venipuncture or history of needle or blood phobia.
• Any other condition that, in the investigator's opinion, may pose a risk to the participant or interfere with the evaluation of study results.

Additional Exclusion Criteria for Female Participants:

• Pregnant or lactating women, or women with a positive pregnancy test.
• Unwilling to use effective contraception during the study and for a specified period thereafter.