A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

A Randomized, Open-Label, Phase I Clinical Study on SHR6390 of Different Specifications After Process Modification in Healthy Chinese Volunteers

This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.

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.