A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

Inclusion criteria

• Healthy Chinese male and female aged 18-45years with a minimum weight of 50 kg for male and 45 kg for female subjects and a body mass index (BMI) of 18-26 kg/m2 who provided written informed consent for participating in the study.
• Without history of cardiovascular, hepatic, kidney, pulmonary, endocrine, gastrointestinal, neurological, or psychiatric disease.
• No pregnancy plan during the trial or within 6 months after completion of the trial.
• Voluntarily signed the informed consent form and strictly adherence to the study protocol.

Exclusion criteria

• vital signs, physical examination, 12-lead electrocardiogram, and laboratory examination had results of clinical significance.
• Hepatitis B and C, human immunodeficiency virus (HIV) and syphilis antibody positive;
• Any history of allergy, alcohol and drug abuse;
• blood donation, massive blood loss (≥400mL).
• Participated in other clinical trials within three months. (6) Severe infection or surgery four weeks prior to screening;
• use of any drug that inhibits or induces hepatic metabolizing enzymes four weeks prior to screening;
• use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products fourteen days prior to screening;
• A history of dysphagia, gastrointestinal ulcers, or any gastrointestinal disease that interferes with drug absorption.