This is a single-center, randomized, double-blind, placebo-controlled study . The objective is to evaluate the safety , tolerability and PK profile of KHN707 tablets in Chinese healthy participants.
1.Age: 18 to 45 years old (inclusive), Male or female.
2.Body weight: ≥ 50 kg for male and ≥ 45 kg for female, body mass index: 19~26 kg/m2 (inclusive).
3. Effective contraception measures and no sperm/egg donation plan from signing the informed consent to 3 months after last dose.
4.Fully understand the procedures and sigh the informed consent.
1. Participants with clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram, laboratory tests, abdominal ultrasound , or chest X-ray as judged by the investigator during screening .
2.Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) and/or bilirubin above the upper limit of normal, or creatinine (Cr) above the upper limit of normal at screening or baseline.
3.Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum antibody at ScreeningDysphagia or history of gastrointestinal diseases, liver and kidney diseases that can affect the pharmacokinetic behavior of drugs as judged by the investigator.
4.Participants with medical history of clinically significant conditions that may affect the study per investigator assessment-including but not limited to disorders of the central nervous, cardiovascular, respiratory, digestive, urinary, endocrine, hematologic or immune systems; malignancies; metabolic disorders; any physiological conditions interfering with trial results; or psychiatric/cerebral dysfunction disorders based on investigator determination of unsuitability..
Sequential
KHN707 tablet
DrugParticipants will receive a single dose or two doses of KHN707 tablets orally in a fasting or fed state.
Placebo
DrugAll participants will receive a single dose or two doses of the placebo in a fasting or fed state.
The incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs), vital signs, physical examination, laboratory tests, electrocardiogram (ECG), etc.
Maximum observed plasma concentration (Cmax)
To characterise the PK of KHN707 following oral administration of KHN707.
Time to reach maximum observed concentration (Tmax)
To characterise the PK of KHN707 following oral administration of KHN707.
Area under plasma concentration-time curve from zero to infinity (AUC0-inf)
To characterise the PK of KHN707 following oral administration of KHN707.
Terminal elimination half-life (t1/2)
To characterise the PK of KHN707 following oral administration of KHN707.
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