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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00688779

Acronym

SAD

Enrollment

130

Registered

2008-06-03

Start date

2008-01-31

Completion date

2009-04-30

Last updated

2015-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Healthy

Keywords

Healthy male, allergic rhinitis, tolerability, safety, intranasally, Healthy subjects

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

Interventions

DRUGAZD8848

Concentrate for nasal spray,solution 60 mg/g

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry	During the study

Secondary

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026