Beijing Puqi Pharmaceutical Technology Co Ltd.

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。

This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time.
The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis.
Participants will:
* Use PG-011gel or a placebo twice daily for initial 8 weeks, and followed by using PG-011 gel for all of the participants till 52-week.
* Visit the clinic at weeks 1, 2, 4 and 8 for checkups and tests, and followed by visiting the clinic every 4 weeks till 52-week.
* Keep a diary of their symptoms.

评估PG-011凝胶（II）在健康成人受试者中的安全性、耐受性和药代动力学特征