Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

Healthy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00688779
• Other study ID #: D0540C00001
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2008
• Last updated: August 13, 2015
• Start date: January 2008
• Est. completion date: April 2009

Study information

• Verified date: August 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2009
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Healthy
• Rhinitis
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• AZD8848
Concentrate for nasal spray,solution 60 mg/g
• Placebo

Locations

Country	Name	City	State
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry		During the study	No
Secondary	Clinical chemistry, haematology, urinalysis		During the study	No
Secondary	Nasal symptoms and peak nasal inspiratory flow		During the study	No
Secondary	Pharmacokinetics		During the study	No
Secondary	Biomarkers nasal lavage and blood		During the study	No

External Links

•   CSR Synopsis