Beijing Kawin Bio-Tech Co. Ltd.

To evaluate the drug-drug interactions between KW-136 capsules and sofosbuvir tablets, as well as the pharmacokinetic properties and tolerability of the combination of KW-136 capsules and sofosbuvir tablets in healthy subjects, and to provide a basis for the design of dosing regimens in subsequent clinical trials.

(1) To evaluate the tolerability of KW-136 capsules after multiple doses and single/multiple administrations in patients with HCV infection; (2) To evaluate the pharmacokinetics of KW-136 capsules after multiple doses and single/multiple administrations in patients with HCV infection; (3) To evaluate the antiviral activity of KW-136 capsules after multiple doses and single/multiple administrations in patients with HCV infection.

To evaluate the safety and tolerability of single and multiple doses of KW-136 capsules in healthy subjects, and determine the maximum tolerated dose; to evaluate the pharmacokinetic characteristics of single and multiple doses of KW-136 capsules in healthy subjects, and to explore the dynamic changes of its absorption, metabolism and elimination in the body; to evaluate the effect of food on the pharmacokinetics of oral KW-136 capsules in healthy subjects. To provide a reference for the safe dosage range, administration method, dosage range and administration mode of later clinical trials.