Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Phase 1
Completed
- Conditions
- HealthyAllergic Rhinitis
- Interventions
- Drug: AZD8848Drug: Placebo
- Registration Number
- NCT00688779
- Lead Sponsor
- AstraZeneca
- Brief Summary
Investigate safety/tolerability after a single dose intranasal administration of AZD8848 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 130
Inclusion Criteria
- History of birch and/or timothy grass pollen induced seasonal allergic rhinitis for at least the previous 2 years
- Body mass index (BMI) between 19 and 30 kg/ m2 and a weight between 50 and 100 kg
- No clinically relevant abnormal findings
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Exclusion Criteria
- Acute illness which requires medical intervention
- Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
- Clinical relevant disease or disorder (past or present)
- A history of asthma
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD8848 - 2 Placebo -
- Primary Outcome Measures
Name Time Method Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry During the study
- Secondary Outcome Measures
Name Time Method Clinical chemistry, haematology, urinalysis During the study Nasal symptoms and peak nasal inspiratory flow During the study Pharmacokinetics During the study Biomarkers nasal lavage and blood During the study
Trial Locations
- Locations (1)
Research Site
🇸🇪Lund, Sweden