[Translation] A Phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics, and relative bioavailability of XJN026 nasal spray in healthy adult participants with single and multiple dose escalations.
第一阶段
主要目的: 评估不同剂量XJN026鼻喷雾剂在健康成年试验参与者中单次和多次给药后的安全性和耐受性及局部安全性。
次要目的: 评估不同剂量XJN026鼻喷雾剂在健康成年试验参与者中单次和多次给药后的药代动力学(PK)特征。
第二阶段
主要目的: 评估XJN026鼻喷雾剂相对于对照药苯甲酸利扎曲普坦片的生物利用度(BA)。
次要目的: 评估XJN026鼻喷雾剂的PK特征。 评估XJN026鼻喷雾剂的安全性。
[Translation] Phase 1
Primary Objective: To evaluate the safety, tolerability, and local safety of different doses of XJN026 nasal spray after single and multiple administrations in healthy adult participants.
Secondary Objective: To evaluate the pharmacokinetic (PK) characteristics of different doses of XJN026 nasal spray after single and multiple administrations in healthy adult participants.
Phase 2
Primary Objective: To evaluate the bioavailability (BA) of XJN026 nasal spray relative to the control drug rizatriptan benzoate tablets.
Secondary Objectives: To evaluate the PK characteristics of XJN026 nasal spray. To evaluate the safety of XJN026 nasal spray.