Study design and treatment
SAD
The Institutional Ethics Committees of the Affiliated Hospital of Southwest Medical University (Luzhou, China; approval number: L2022040) and Chengdu Fifth People’s Hospital (Chengdu, China; approval number: 2021-013-01) approved this study. Written informed consent was obtained from all the patients.This dose-escalation study included an approximately 14-day screening period, a 2-day run-in period, a 3-day SAD period, and a 13-day MAD period. Seven dose cohorts (30 mg, 50 mg, 60 mg, 90 mg, 120 mg, 150 mg, and 180 mg) were studied. Following the screening period, eligible patients were admitted to the hospital on Day − 2 for diet control (the run-in period). Then, the patients were sequentially assigned to each dose cohort before treatment. During the SAD period, the patients were administered a single dose of HP501 on Day 1 under fasting conditions and observed for 3 days for tolerability. If patients had acceptable safety in the SAD test, the MAD test was conducted. The patients received HP501 once daily from Days 4 to 13 under fasting conditions for 10 days. Dose escalation was performed only after the previous dose was assessed for acceptable safety and tolerability.