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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No: 2009-016611-38 |
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The aim of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5423 following multiple ascending dose administrations in healthy male and female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Drug: AZD5423 |
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| B | Placebo Comparator | Drug: Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5423 | Drug | Suspension for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. Starting dose as determined from SAD study and with up to 4 dose escalations not exceeding AstraZeneca pre-defined exposure limits. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables: adverse events | Assessment taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up visit. Volunteers will be monitored throughout the study for adverse events. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics profile: concentration of AZD5423 in plasma | Samples taken at defined timepoints pre-dose and post-dose during treatment periods. Samples taken at approx. 39 timepoints. | |
| Investigation of PD effects | Samples taken at screening visit, defined timepoints pre-dose and post-dose during treatment periods and follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darren Wilbraham | Quintiles Drug Research Unit at Guy's Hospital, London, UK | Principal Investigator |
| Jorup Carin | AstraZeneca R&D, Lund, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London Bridge | Greater London | United Kingdom |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C587250 | 2,2,2-trifluoro-N-(1-((1-(4-fluorophenyl)-1H-indazol-5-yl)oxy)-1-(3-methoxyphenyl)-2-propanyl)acetamide |
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| Placebo | Drug | Solution for nebulisation, inhaled. Each subject will receive an inhaled dose of AZD5423 or placebo once daily for 14 days. |
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