Beijing Puqi Pharmaceutical Technology Co Ltd.

The study is a multicenter, randomized, double-blind, placebo-controlled seamless and adaptive-designed phase IIb/III study encompassing a phase IIb and a phase III component. The phase IIb study, which is registered this time, is a dose-ranging component. The phase III study is a pivotal part of the overall research.
The goal of this phase IIb study is to evaluate the efficacy, safety, and pharmacokinetics of PG-011 nasal spray across various dosages and administration frequencies for treating adults with moderate to severe seasonal allergic rhinitis (SAR). Investigators will compare PG-011 nasal spray to a placebo (a look-alike substance that contains no drug) to see which dosage and frequency works to treat moderate to severe seasonal allergic rhinitis.

评价健康受试者多次口服剂量递增 PG-018 片的安全性、耐受性、药代动力学特征及食物对药代动力学的影响

评价不同剂量PG-011鼻喷雾剂在治疗中重度季节性过敏性鼻炎受试者中的安全性、有效性和药代动力学特征。