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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: May 29, 2008
Last updated: August 13, 2015
Last verified: August 2015
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

Condition Intervention Phase
Healthy Allergic Rhinitis Drug: AZD8848 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry [ Time Frame: During the study ]

Secondary Outcome Measures:
  • Clinical chemistry, haematology, urinalysis [ Time Frame: During the study ]
  • Nasal symptoms and peak nasal inspiratory flow [ Time Frame: During the study ]
  • Pharmacokinetics [ Time Frame: During the study ]
  • Biomarkers nasal lavage and blood [ Time Frame: During the study ]

Enrollment: 130
Study Start Date: January 2008
Study Completion Date: April 2009
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AZD8848
Concentrate for nasal spray,solution 60 mg/g
Placebo Comparator: 2 Drug: Placebo


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00688779

Research Site
Lund, Sweden
Sponsors and Collaborators
Principal Investigator: Edward Högestätt Department of Clinical Chemistry and Pharmacology, Department of Laboratory Medicine on University Hospital Lund, Sweden
Study Director: Leif T Eriksson AstraZeneca R&D, Lund
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT00688779     History of Changes
Other Study ID Numbers: D0540C00001
Study First Received: May 29, 2008
Last Updated: August 13, 2015

Keywords provided by AstraZeneca:
Healthy male
allergic rhinitis
Healthy subjects

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on September 21, 2017