E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
BLX000441-002 is intended for the treatment of seasonal allergic rhinitis.
The primary objective in this study is to evaluate the time-to-onset of action of BLX000441-002 nasal spray compared with placebo, as measured by alfa2-macroglobulin levels, after a single dose in healthy volunteers
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are: - to evaluate the Total Nasal Symptom Score of BLX000441-002 nasal spray compared with placebo after a single dose in healthy volunteers - to evaluate the safety of BLX000441-002 nasal spray
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Written informed consent to participate in the study obtained 2. Male or female subject aged 18-50 years, extremes included 3. Body Mass Index between 18 and 28 kg/m2 , extremes included 4. Good age-related health condition as judged by the investigator and established by medical history and physical examination at the screening visit. 5. Negative skin prick test
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E.4 | Principal exclusion criteria |
1. Known hypersensitivity to cetirizine or any of the other compounds of the investigational products 2. Positive screen for HIV, Hepatitis B and/or C 3. Current smoker, or a history of smoking more than 10 cigarettes a day over a period of at least 5 years. 4. Soy bean and peanut allergy. 5. Therapy with any drug (for two weeks preceding dosing) except for occasional analgesics and hormonal contraceptives 6. Relevant history of or current condition that in the opinion of the investigator might interfere with the therapeutic effect of the investigational product. 7. History of or current abuse of drugs or alcohol or solvents 8. Women who are pregnant, lactating or likely to become pregnant during the course of the study, or women of child bearing potential not using adequate contraception (i.e. hormonal contraception or barrier methods) 9. Participating in any other investigational study in the last 30 days 10. Subject not able to communicate with the investigator 11. Inability to adhere to study plan |
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E.5 End points |
E.5.1 | Primary end point(s) |
Alfa2-macroglobulin is used as a measure of the amount of plasma exudation after, in this study, a histamine challenge |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial is when all healthy volunteers have received both the placebo an active treatment (single doses). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |