研究单位：[1]Beijing Tongren Hospital[2]Prime Gene Therapeutics Co., Ltd.[3]Beijing Shijitan Hospital, Capital Medical University,Beijing,Beijing,China[4]Beijing Youan Hospital, Capital Medical University,Beijing,Beijing,China[5]Luo Yang First People''s Hospital,Luoyang,He Nan,China[6]Cangzhou Central Hospital,Cangzhou,Hebei,China[7]Hebei Petro China Central Hospital,Langfang,Hebei,China[8]Zhengzhou Central Hospital,Zhengzhou,Henan,China[9]The Central Hospital of Wuhan,Wuhan,Hubei,China[10]Shengjing Hospital of China Medical University,Shenyang,Liaoning,China[11]Baotou Central Hospital,Baotou,Neimenggu,China[12]Chifeng Municipal Hospital,Chifeng,Neimenggu,China[13]Shandong Second Provincial People''s Hospital,Jinan,Shandong,China[14]Liaocheng People''s Hospital,Liaocheng,Shandong,China[15]Yantai YuHuangDing Hospital,Yantai,Shandong,China[16]Zibo Central Hospital,Zibo,Shandong,China[17]Linfen Central Hospital,Linfen,Shanxi,China[18]Linfen People''s Hospital,Linfen,Shanxi,China[19]First Hospital of Shanxi Medical University,Taiyuan,Shanxi,China[20]The First Affiliated Hospital of Xi''an Jiao Tong University,Xi''an,Shanxi,China[21]Yuncheng Central Hospital,Yuncheng,Shanxi,China
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.
