A double blind, randomized, cross-over, placebo controlled study, evaluating the time-to-onset of action of BLX000441-002 nasal spray in healthy volunteers. - Time to Onset
- Conditions
- healthy volunteers
- Registration Number
- EUCTR2004-002807-33-SE
- Lead Sponsor
- Biolipox AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
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
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: BLX000441-002 is intended for the treatment of seasonal allergic rhinitis.<br><br>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<br>;Secondary Objective: The secondary objectives are:<br>- to evaluate the Total Nasal Symptom Score of BLX000441-002 nasal spray compared with placebo after a single dose in healthy volunteers<br>- to evaluate the safety of BLX000441-002 nasal spray<br>;Primary end point(s): Alfa2-macroglobulin is used as a measure of the amount of plasma exudation after, in this study, a histamine challenge
- Secondary Outcome Measures
Name Time Method