Allergic rhinitis
Conditions
Interventions
Experimental Group:Administration of PG-011: In the morning of Day 1, 1.2 mg of PG-011 is administered via nasal spray under fasting conditions.
Administration of [14C] PG-011: Approximately 1.5 hours
Sponsors
Beijing GoBroad Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Participants must be fully informed about the trial before participating, including the trial content, procedures, and any potential adverse events related to the investigational drug, and must sign the informed consent form voluntarily. 2. Male adult participants aged 18 to 45 years (inclusive). 3. At screening, participants must weigh no less than 50 kg, with a body mass index (BMI) in the range of 19.0 to 26.0 kg/m² (inclusive). 4.Participants have no plans to donate sperm within 6 months after administration, and both the participants and their partners no plans plan to conceive during the study period or within 6 months after administration and must voluntarily implement effective contraceptive measures to prevent pregnancy of the subject's partner.
Exclusion criteria
Exclusion criteria: 1. The investigator judges whether the participants have clinically significant diseases or medical history that can’t adhering to study protocol the study protocol and completing this study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, mental system, endocrine and metabolic system, etc. 2. Participants have any nasal or oropharyngeal diseases that may affect drug absorption, or having undergone nasal surgery and nasal trauma, etc., which the investigator considers clinically significant, including but not limited to any past medical history or current medical history that may affect the safety of the trial or the internal process of the drug, especially those with any nasal diseases that affect drug absorption, a) Medical history with long-term nasal congestion, runny nose, nasal itching, headache, nosebleeds and other symptoms, b) Asthma, chronic respiratory diseases, etc., c) History of nasal surgery, trauma, allergic rhinitis, chronic rhinitis, sinusitis, severe deviation of the nasal septum, etc. 3. Participants have lung disease that may affect the drug study, including but not limited to chronic obstructive pulmonary disease, bronchial infection, tracheitis, etc. 4. Participants have a history of tuberculosis, or the examination results (T-SPOT test, chest X-ray, etc.) at screening suggest active or occult tuberculosis infection. 5. Participant has clinically infection significant, injury and disease within 1 month. Participant who has a history of shingles infection within 1 year. 6. Participants have abnormal vital sign examination, physical examination, routine laboratory examination (blood routine, urine routine, stool routine occult blood, blood biochemistry, coagulation function), 12-lead electrocardiogram, chest X-ray (upright), abdominal B-ultrasound and other examinations that has clinically significant at screening or baseline. 7. Participants have the following results of 12-lead ECG during the screening period or baseline period: QTcF=450 ms, or other indicators of electrocardiogram are abnormal and clinically significant. 8. Positive results of hepatitis B surface antigen quantitative assay, hepatitis C antibody assay, Treponema pallidum antibody assay, and human immunodeficiency virus antigen antibody assay. 9. Any surgical procedure that may affect drug metabolism and excretion (such as cholecystectomy, except appendicitis surgery), or those who plan to undergo surgery during the trial. 10. Hemorrhoids with blood in the stool or perianal diseases with regular or ongoing blood in the stool, or severe nausea and vomiting within one week prior to screening, or habitual constipation or diarrhea, or positive fecal occult blood test. 11. Participants use any prescription drugs, over-the-counter drugs, Chinese herbal medicines, food supplements (including vitamins, health foods, etc.) within 14 days before administration, or other non-drug treatment factors that affect drug absorption, distribution, metabolism, and excretion. 12. Participants have a history of drug allergy or allergic disease (such as asthma, urticaria, eczematous dermatitis, etc.), or may or definitively allergic to the investigational drug (including the similar drugs) and any of its excipients which judged by the investigator. 13. Participants received any other investigational drugs or participated in any other
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total radioactive recovery rate and the cumulative total radioactive recovery rate of excreta (urine and feces) over each time interval. ;Total radiopharmaceutical pharmacokinetic parameters in plasma and whole blood (if applicable): Cmax;Total radiopharmaceutical pharmacokinetic parameters in plasma and whole blood (if applicable): Tmax;Total radiopharmaceutical pharmacokinetic parameters in plasma and whole blood (if applicable): t1/2 ;Total radiopharmaceutical pharmacokinetic parameters in plasma and whole blood (if applicable): MRT ;Total radiopharmaceutical pharmacokinetic parameters in plasma and whole blood (if applicable): AUC ;The ratio of total radioactivity concentration in whole blood to that in plasma.;Percentage of total plasma radioactive drug and its metabolites (if applicable) in plasma.;The percentage (%Dose) of radioactive parent drugs and their metabolites (if applicable) in urine and feces relative to the administered dose. ;Identification of major metabolites in plasma, urine, and feces.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of [14C] PG-011 (if applicable), PG-011 and its main metabolites (if applicable) in plasma: Cmax.;Pharmacokinetic parameters of [14C] PG-011 (if applicable), PG-011 and its main metabolites (if applicable) in plasma: Tmax;Pharmacokinetic parameters of [14C] PG-011 (if applicable), PG-011 and its main metabolites (if applicable) in plasma: t1/2;Pharmacokinetic parameters of [14C] PG-011 (if applicable), PG-011 and its main metabolites (if applicable) in plasma: MRT;Pharmacokinetic parameters of [14C] PG-011 (if applicable), PG-011 and its main metabolites (if applicable) in plasma: AUC;The absolute bioavailability (F) of PG-011 nasal spray administration.; | — |
Countries
Beijing
Contacts
Public ContactQuankun Zhuang
Beijing GoBroad Hospital
Outcome results
None listed