Safety assessments
Twelve-lead electrocardiography (ECG), vital signs (respiration, blood pressure, pulse, and temperature), physical examinations, and laboratory tests (routine urine tests, routine blood tests, blood biochemical tests, and serum and urinary beta 2-microglobulin) were used to evaluate the safety and tolerability of HP501. All AEs and serious AEs (SAEs), as well as their severities, were recorded. The AEs were coded using the Medical Dictionary for Regulatory Activities (version 24.0).