Male subjects with seasonal allergic rhinitis to grass but otherwise healthy MedDRA version: 12.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis
Conditions
Interventions
Product Code: UR-63325
Pharmaceutical Form: Capsule*
Current Sponsor code: UR-63325
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the p
Sponsors
PALAU PHARMA, S.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Caucasian males between the ages of 18 and 55 2. No clinically relevant abnormal physical findings at the screening examination 3. No clinically relevant abnormal ECG at the screening examination 4. No clinically relevant abnormal resting blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and resting heart rate (50-100 bpm) 5. Body Mass Index of 19.0-29.9 (kg/m2) 6. Ability to communicate well with the investigator and to comply with the requirements of the entire study. 7. Availability for daily telephonic follow-up and willingness to provide contact details to be located at any time during the treatment days. 8. Provision of written informed consent to participate (prior to any study-related procedures being performed) as shown by a signature on the volunteer consent form and to be able to adhere to the study restrictions and examination schedule 9. Subjects with history of seasonal allergic rhinitis to grass within the previous two years 10. Positive skin prick test to timothy grass pollen (wheal difference with negative control = 3 mm) at screening 11. Subjects with positive response to screening nasal challenge with increasing doses of timothy grass pollen (symptoms worsening (TNSS=4-6) within one hour after last nasal allergen challenge) 12. Baseline FEV1 80% predicted and baseline FEV1/FVC 70% predicted 13. In case of sexually active men who have not been sterilized surgically, use of a double contraception method during intercourse to prevent a pregnancy from possibly damaged sperm: -intrauterine device (IUD) or hormonal contraception plus condom or diaphragm or spermicide, or -condom plus diaphragm, or -abstinence during the clinical study until the Follow-up visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Symptoms of allergic rhinitis within 2 weeks prior to screening 2. Upper respiratory infection or sinusitis within 14 days of screening and also within 14 days of study start in each of the two periods 3. Structural nasal abnormalities or nasal polyps on examination, a history of nose bleeding or recent nasal surgery 4. History of asthma or asthmatic symptoms or other respiratory disease other than rhinitis within the last 2 years or FEV1 5 cigarettes per day or unwilling to stop smoking for the duration of study (screening to end of follow-up) 16.Drinker of more than 5 cups daily of beverage containing caffeine 17.Daily alcohol intake bigger than 3 units per day (one unit=8 g or about 10 mL of pure alcohol) or unwilling to stop alcohol intake for the duration of the study (screening to end of follow-up) 18.History of drug dependence other than tobacco within the past 2 years 19.Positive urine drug screen for drugs 20.Subjects with any clinically significant abnormality following review of pre-study laboratory tests or on direct questioning and physical examination, including known or suspected HIV, HBV and HCV infection 21.Subjects with sucrose intolerance 22.Subjects who forfeit their freedom by administrative or legal award or who are under guardianship 23.Subjects who are unwilling to give their informed consent 24.Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the activity of UR-63325 in a model of allergic rhinitis induced by nasal allergen challenge to known allergic rhinitis patients otherwise healthy, through clinical and physiological measures including sneezing, TNSS (total nasal symptom score) and nasal peak inspiratory flow.;Secondary Objective: - To explore the pharmacokinetics of UR-63325 and metabolites in plasma after administration of repeated oral doses for 7 days. - To explore the biological effects of UR-63325 in known allergic rhinitis patients otherwise healthy through effect on several markers of inflammation and allergic reactions, including cytokines in nasal exudates, and overall leukocyte and differential leukocyte density in nasal lavage. - To describe the profile of adverse effects of UR-63325 in known allergic rhinitis patients otherwise healthy after 7 days of administration.;Primary end point(s): - The primary endpoint will be the change from screening in the nasal and ocular scores at each time point after nasal allergen challenge. - The maximum score and the time course and AUC of symptoms will be compared for each of the treatment groups. Individual clinical symptoms and number of sneezes will be also compared. | — |
Countries
Germany
Outcome results
None listed