A Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis

Exclusion Criteria

• •1. Participants are diagnosed of active or latent tuberculosis infection.
• •2. Participants are diagnosed of moderate to severe asthma.
• •3. Participants who had active pulmonary diseases or infections (including but not limited to bronchitis, pneumonia), upper respiratory tract infections or sinus infections within 4 weeks before screening, and/or those who had respiratory infections during the lead-in period.
• •4. Participants received nasal or sinus surgery within 3 months before screening or had nasal trauma that had not fully healed.
• •5. Any nasal mucosal erosion, nasal septal ulcer, nasal septal perforation or other nasal diseases that, as judged by the investigator, may affect the deposition of drugs in the intranasal, such as acute or chronic sinusitis, drug-induced rhinitis, nasal polyps, etc.
• •6. Participants has ocular herpes simplex or other ocular infections (except seasonal allergic conjunctivitis).
• •7. Participants with facial or systemic fungal, bacterial, viral or parasitic infections, or oral infections that had not been cured and still required continuous treatment within 4 weeks before screening.
• •8. Participants have severe diseases such as central nervous system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system or blood system, which may affect the judgment of efficacy and safety .
• •9. Participants who were infected with human immunodeficiency virus (HIV) at the time of screening, those in the active stage of hepatitis C virus (HCV) infection (anti - HCV positive), those in the active stage of hepatitis B virus (HBV) infection (HBV - DNA \> 2000 IU/mL or 10⁴ copies/mL), or those with positive Treponema pallidum antibody indicating an active stage of infection.
• •10. Any drug treatments before lead-in period, such as use of nasal or systemic decongestants and anticholinergic drugs within 3 days, use of antihistamines such as cetirizine, fexofenadine, and loratadine within 5 days, systemic use of glucocorticoids within 4 weeks, or local use of glucocorticoids, mast cell stabilizers, tricyclic antidepressants, and leukotriene receptor antagonists within 2 weeks, and use of anti - allergic Chinese herbal medicines within 2 weeks.
• •11. During the trial, participants who cannot stop using JAK inhibitors, tricyclic antidepressants, glucocorticoids, decongestants, antihistamines (except loratadine, which is a rescue drug required during the treatment), leukotriene receptor antagonists, mast cell stabilizers (including sodium cromoglycate, nedocromil sodium, tetrazolium chromone, nedocromil sodium, pemirolast potassium, and tranilast, etc.), anticholinergic drugs, anti - allergic Chinese herbal medicines, and those who cannot stop using nasal irrigation.
• •12. Participants who have undergone desensitization therapy or received immunotherapy within 6 months prior to screening.
• •13. Participants who are known or judged by the investigator to potentially have an allergic reaction to the active ingredients or excipients of the investigational drug.
• •14. Participants who have a history of intolerance to intranasal administration.
• •15. Participants who plan to travel outside the local area for 2 consecutive days or more during the trial.
• •16. Participants who have participated in other clinical studies of investigational drugs or medical devices within 3 months prior to screening.
• •17. Participants who have a history of drug abuse or alcoholism within 1 year prior to screening
• •18. Female participants who are breastfeeding or pregnant at the time of screening
• •19. Reproductive - age participants (male or female) who plan to become pregnant, breastfeed, or donate sperm/eggs during the study or within 1 month after the study ends
• •20. Any other condition that, in the opinion of the investigator or sponsor, makes the subject unsuitable for participation in the study.