Back to resultsTolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season (SAD)
Primary Purpose
Healthy, Allergic Rhinitis
Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
AZD8848
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Healthy male, allergic rhinitis, tolerability, safety, intranasally, Healthy subjects
Eligibility Criteria
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
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
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
Secondary Outcome Measures
Clinical chemistry, haematology, urinalysis
Nasal symptoms and peak nasal inspiratory flow
Pharmacokinetics
Biomarkers nasal lavage and blood
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00688779
Brief Title
Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Acronym
SAD
Official Title
A Double Blind, Placebo Controlled, Randomised, First Time In Man. Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of AZD8848 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out Of Season
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Allergic Rhinitis
Keywords
Healthy male, allergic rhinitis, tolerability, safety, intranasally, Healthy subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZD8848
Intervention Description
Concentrate for nasal spray,solution 60 mg/g
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
Time Frame
During the study
Secondary Outcome Measure Information:
Title
Clinical chemistry, haematology, urinalysis
Time Frame
During the study
Title
Nasal symptoms and peak nasal inspiratory flow
Time Frame
During the study
Title
Pharmacokinetics
Time Frame
During the study
Title
Biomarkers nasal lavage and blood
Time Frame
During the study
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Högestätt
Organizational Affiliation
Department of Clinical Chemistry and Pharmacology, Department of Laboratory Medicine on University Hospital Lund, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leif T Eriksson
Organizational Affiliation
AstraZeneca R&D, Lund
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Lund
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
22726593
Citation
Greiff L, Cervin A, Ahlstrom-Emanuelsson C, Almqvist G, Andersson M, Dolata J, Eriksson L, Hogestatt E, Kallen A, Norlen P, Sjolin IL, Widegren H. Repeated intranasal TLR7 stimulation reduces allergen responsiveness in allergic rhinitis. Respir Res. 2012 Jun 22;13(1):53. doi: 10.1186/1465-9921-13-53.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1656&filename=D0540C00001_Study_Synopsis.pdf
Description
CSR Synopsis
Learn more about this trial
Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
We'll reach out to this number within 24 hrs