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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022574-14 | EudraCT Number |
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The study will investigate how the dose of AZD8848 and the dosing frequency will affect the immunological/inflammatory response by measuring the production of biomarkers in blood and nasal lavage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Placebo given once daily on 7 days |
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| 2 | Experimental | Active treatment at Day 1 and Day 7. Placebo on Day 2, 3, 4, 5 and 6 |
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| 3 | Experimental | Active treatment at Day 1, 4 and 7. Placebo on Day 2, 3, 5 and 6. |
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| 4 | Experimental | Active treatment at Day 1, 3, 5 and 7. Placebo on Day 2, 4 and 6. |
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| 5 | Experimental | Active treatment once daily on 7 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD8848 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage | Samples collected pre-dose and 1 day after first dose. | |
| CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage | Samples collected pre-dose and 7 days after first dose. | |
| CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage | Samples collected pre-dose and 8 days after first dose. | |
| CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage | Samples collected pre-dose and 10 days after first dose. | |
| CXCL 10 (IP-10) and mRNA expression of IFNα regulated genes in blood and nasal lavage | Samples collected pre-dose and 12-14 days after first dose. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess safety and tolerability of intranasal administration of AZD8848 at different doses and dosing regimens | During the 7 days dosing period and at four follow-up visits up to 11-13 months after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leif T Eriksson, MD, PhD | AstraZeneca | Study Director |
| Wolfgang Kuhn, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Uppsala | Sweden |
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| Label | URL |
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| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| C000609563 | AZD8848 |
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| Placebo | Drug | Placebo |
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