A study to investigate the impact of dose and dosing frequency of AZD8848 on the response on biomarkers
Study identifier:D0540C00016
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-022574-14
CTIS identifier:N/A
Study Complete
Official Title
A single-blind, randomized, placebo controlled, parallel-group, adaptive-design study to investigate the impact of dose and dosing frequency of AZD8848 administered intranasally for up to 7 days, on the biomarker
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD8848, Placebo
Sex
All
Actual Enrollment
55
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Nov 2010
Primary Completion Date: 01 Mar 2011
Study Completion Date: 01 Feb 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Aug 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 Placebo given once daily on 7 days | Drug: Placebo Placebo |
| Experimental: 2 Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6 | Drug: AZD8848 The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo. Drug: Placebo Placebo |
| Experimental: 3 Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6. | Drug: AZD8848 The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo. Drug: Placebo Placebo |
| Experimental: 4 Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6. | Drug: AZD8848 The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo. Drug: Placebo Placebo |
| Experimental: 5 Active treatment once daily on 7 days | Drug: AZD8848 The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo. |
Contacts
Investigators
Principal Investigator
Leif T Eriksson
AstraZeneca
