The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects.

Inclusion Criteria:

• Able to comprehend and sign the ICF voluntarily prior to initiate the study;
• Able to complete the study according to the protocol;
• Between 18 and 45 years of age（18 and 45 are inclusive）;
• Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）;
• Physical examination and vital signs without clinically significant abnormalities.

Exclusion Criteria:

• Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;
• Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of beer, or 25 mL of strong wine, or 100 mL of grape wine);
• Donated blood or massive blood loss within 3 months before screening (>450 mL）;
• Have any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers;
• Have take any drug that changes liver enzyme activity within 1 month before taking the study drug
• Have taken any prescription drug, over-the-counter drug, vitamin product or herbal medicine within 14 days prior to screening;
• Have participated in any clinical trial or taken any study drug within 3 months before dosing;
• Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or syphilis.
• Have taken any alcoholic products within 24 hours prior to taking the study drug