Allergic Rhinitis
Conditions
Interventions
experimental group:PG-011 nasal spray, intranasal administration, single and multiple dose
control group:Placebo, intranasal administration, single and multiple dose
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Participants fully understands the purpose, nature, method and possible AE in the study, willing to compile with the requirements of the study, and willing to sign the informed consent form (ICF) before the start of any research procedure, and participates all research procedure by him/herself. 2. Participants aged 18~55 (including cut-off values) , male and female . 3. Body mass index (BMI) is betwwn19.0 and 28.0 kg/m2. 4. Participants have no abnormalities , or the abnormality has no clinical significance confirmed by investigator. 5. Willingness to avoid pregnancy or fathering children based on the criteria as outlined in the protocol.
Exclusion criteria
Exclusion criteria: 1. Those who have diseases such as circulatory system, endocrine system, blood system, respiratory system, digestive system, urinary system, immune system, central nervous system or psychiatry, or have any history of serious clinical diseases (such as a history of malignant tumors) or abnormal clinical laboratory examinations have clinical significance; 2. Have any nasal or oropharyngeal disease that may affect drug absorption, or have nasal surgery and nasal trauma which has clinical significance. a) The medical history includes symptoms such as long-term nasal congestion, runny nose, nasal itching, headache, and nosebleeds; b) Asthma, chronic respiratory diseases, etc. c) Those with a history of nasal surgery, trauma, allergic rhinitis, chronic rhinitis, sinusitis, severe deviation of the nasal septum, etc., and whom the researcher considers still clinically significant at present. 3. Have lung disease including but not limited to chronic obstructive pulmonary disease, bronchial infection, bronchitis, etc. 4. Those who received major surgery within 4 weeks before screening, or who will receive major surgery during the trial. 5. Those who are allergic to PG-011 or any component in the PG-011gel,or who have specific allergies history (asthma, urticaria, eczema, etc.), or allergic constitution., a. 6. Those who have active or untreated latent tuberculosis (TB). 7. Those who have invasive fungal infection (cryptococcal disease and pulmonary cysticercosis) or chronic, active or acute infections requiring systemic treatment of antibiotics, antivirals, antiparasitic drugs, antiprotozoal drugs, and antifungals, or unusual frequent, recurrent, or long-term infection 14 days before screening. 8. Abnormal ECG examination has clinical significance, If QTc > 450 ms(for males) or QTc > 470 ms(for females), and the PR interval > 200 ms; The duration of the QRS complex is > 120ms; Or there has been torsion of the tip type ventricular tachycardia or other risk factors that can lead to malignant arrhythmias (such as heart failure, angina pectoris, etc.); Or have a history or family history of short QT syndrome or long QT syndrome (such as unexplained sudden death, drowning or sudden infant death syndrome during youth). 9. Hepatitis B surface antigen qualitative, hepatitis C virus antibody, hepatitis C virus core antigen, human immunodeficiency virus [HIV] antigen antibody combination test, treponemal specific antibody test any test result positive. 10. History of alcoholism (Consume 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100ml of wine), or have taken any alcoholic products within 48 hours before administration. 11. Those who smoked more than 5 cigarettes per day within 3 months before screening, or could not stop using tobacco during the test, or had a positive nicotine screening result. 12. Those who have a history of drug abuse, drug use history or positive urine drug screening results within 5 years before screening. 13. Women of childbearing age who have a positive pregnancy test result during the screening period or the test process, and women who are currently breastfeeding. 14. Those who have used any prescription drugs, over-the-counter drugs, vitamin products, health supplements, dietary supplements or Chinese herbal medicines within 28 days prior to screening. Previously used JAK inhibitors. Take any drugs known to cause QT/QTc interval prolongation or drugs with the risk of causing torsional ventricul
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;12-lead ECG;clinical laboratory tests;physical examination;vital signs;Cmax; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;AUC0-inf; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed