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This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential. Pharmacokinetics (what the body does to the drug) and pharmacodynamic (what the drug does to the body) parameters will be also assessed as secondary objectives.
A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-5, single ascending dose AZD7624 | Experimental | Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo. |
|
| Placebo | Placebo Comparator | Subjects will participate in 1 of 5 groups. In each group 6 subjects will receive AZD7624 and 2 subjects will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD7624 | Drug | Single dose inhaled IMP via a nebulizer |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety variables (adverse events, vital signs, body temperature, ECGs, clinical laboratory safety tests and spirometry) | up to 55 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of AZD7624 and assess dose proportionality of the pharmacokinetics following single ascending doses of AZD7624 by assessment of Cmax, t1/2, AUC and CL/F. | Day 1 pre-dose, 5min, 15min, 30min, 1h, 2h, 4h, 6h, 9h,12h, 18h, 24h, 36h, 48h, 56h post dose | |
| Pharmacokinetics of single doses of AZD7624 using the following urine PK parameters: Ae and CLR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sam Lindgren, MD | AstraZeneca Research and Development SE-431 83 Molndal Sweden | Study Director |
| Darren G Wilbraham | Quintiles Drug Research Unit at Guy's Hospital 6 Newcomen St London SE1 1YR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C000628576 | AZD7624 |
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| Placebo to match |
| Drug |
Single dose inhaled Placebo via a nebulizer |
|
| Day 1: during 0-6, 6-12, 12-24 and 24-48 hours post dose. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |