2Y-Biopharma

Main study objectives To evaluate the pharmacokinetic characteristics of GP681/GP1707D07 in subjects with mild hepatic impairment (Child-Pugh: Class A), moderate hepatic impairment (Child-Pugh: Class B) and normal hepatic function, and to provide a basis for the clinical application of GP681 tablets. Secondary study objectives To evaluate the safety of GP681 tablets in subjects with mild hepatic impairment (Child-Pugh: Class A), moderate hepatic impairment (Child-Pugh: Class B) and normal hepatic function.

Main study objectives 1) To evaluate the effect of GP681 tablets on the pharmacokinetic characteristics of rosuvastatin (cohort 1) and digoxin (cohort 2) in healthy Chinese subjects; 2) To evaluate the effect of multiple doses of itraconazole (cohort 3) on the pharmacokinetic characteristics of GP681 and its major metabolite GP1707D07 in healthy Chinese subjects; 3) To evaluate the pharmacokinetic interaction of GP681 and oseltamivir (cohort 4) in healthy Chinese subjects; Secondary study objectives To evaluate the safety of oral GP681 tablets in combination with rosuvastatin calcium tablets, digoxin tablets, itraconazole capsules, and oseltamivir phosphate capsules in healthy Chinese subjects. Exploratory objectives To explore the effects of CYP450 metabolizing enzyme and transporter gene polymorphisms on the pharmacokinetic characteristics and drug interactions of GP681 and its major metabolite GP1707D07 in healthy subjects.

Phase I Main objectives: 1) To evaluate the safety and tolerability of EN002 topical gel in the treatment of non-melanoma skin cancer; Secondary objectives: 1) To evaluate the pharmacokinetic characteristics of EN002 topical gel in subjects with non-melanoma skin cancer; 2) To explore the efficacy of EN002 topical gel in the treatment of non-melanoma skin cancer and provide a basis for the subsequent phase of trial dosing and administration regimen; Phase II Main objectives: 1) To evaluate the anti-tumor efficacy of EN002 topical gel in the treatment of non-melanoma skin cancer and determine the indications; Secondary objectives: 1) To evaluate the efficacy and safety of EN002 topical gel in the treatment of non-melanoma skin cancer; 2) To evaluate the improvement of the quality of life of the subjects.