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This is a two part study. Part I is designed to test single doses of GSK678586A in healthy volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma. Both parts are designed to investigate the safety, tolerability and the way the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline |
|
| Active | Active Comparator | GSK679586 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK679586 | Drug | Active Drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis | Throughout the study | |
| Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Blood sampling | Throughout the study | |
| Effects on blood and lung function. | Throughout the study | |
| Lung function |
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Inclusion criteria:
Additional Inclusion Criteria for Subjects in Part I
• Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
Additional Inclusion Criteria for Subjects in Part II
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Randwick | New South Wales | 2031 | Australia | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22616628 | Derived | Hodsman P, Ashman C, Cahn A, De Boever E, Locantore N, Serone A, Pouliquen I. A phase 1, randomized, placebo-controlled, dose-escalation study of an anti-IL-13 monoclonal antibody in healthy subjects and mild asthmatics. Br J Clin Pharmacol. 2013 Jan;75(1):118-28. doi: 10.1111/j.1365-2125.2012.04334.x. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C582664 | GSK679586 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
Saline |
|
|
| Throughout the study |
| Plasma levels of GSK679586A to determine pharmacokinetic parameters | Throughout the study |
| serum antibodies to GSK679586A | Throughout the study |
| Melbourne |
| Victoria |
| 3004 |
| Australia |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D017670 |
| Sodium Compounds |