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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.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00688779
First received: May 29, 2008
Last updated: June 8, 2009
Last verified: June 2009
History of Changes

May 29, 2008
June 8, 2009
January 2008
May 2008   (final data collection date for primary outcome measure)
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry [ Time Frame: During the study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00688779 on ClinicalTrials.gov Archive Site
  • Clinical chemistry, haematology, urinalysis [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Nasal symptoms and peak nasal inspiratory flow [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Biomarkers nasal lavage and blood [ Time Frame: During the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Healthy
  • Allergic Rhinitis
  • Drug: AZD8848
    Concentrate for nasal spray,solution 60 mg/g
  • Drug: Placebo
  • Experimental: 1
    Intervention: Drug: AZD8848
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Greiff L, Cervin A, Ahlström-Emanuelsson C, Almqvist G, Andersson M, Dolata J, Eriksson L, Högestätt E, Källén A, Norlén P, Sjölin IL, Widegren H. Repeated intranasal TLR7 stimulation reduces allergen responsiveness in allergic rhinitis. Respir Res. 2012 Jun 22;13:53. doi: 10.1186/1465-9921-13-53.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
April 2009
May 2008   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00688779
D0540C00001
No
Leif T. Efiksson, MD, PhD, Medical Science Director, RITA EPT2, AstaZeneca Pharmaceuticals
AstraZeneca
Not Provided
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
AstraZeneca
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP