Statistical analysis
PD
The sample size was determined according to the “Guidelines for clinical pharmacokinetic studies of chemical drugs” by the China National Medical Products Administration, which recommends a sample size of 8 to 12 cases in each dose group for multiple-dose studies in healthy subjects. No formal statistical calculation was used to predefine the sample size.Safety was assessed in all subjects who received at least one dose of SHR7280 or placebo. Plasma drug concentration and PK parameters were analyzed in subjects who received at least one dose of SHR7280 or placebo and had at least one qualified blood sample for plasma drug concentration and PK parameter assessment. PD parameters were evaluated in subjects who received at least one dose of SHR7280 or placebo and had at least one qualified sample for PD assessment.Baseline characteristics, safety data, and parts of PK and PD parameters were summarized using descriptive statistics. The relationship between PK parameters and dose after log transformation was analyzed using ANOVA model. The AUC of PK and PD parameters were analyzed using a non-compartment model. Statistical analyses were conducted using SAS v9.4 and Phoenix v8.2 or higher (for PK and PD data; Certara, Princeton, NJ, USA).