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The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV ABT-308 in asthmatics | Experimental | ABT-308 single escalating doses in mild to moderate asthmatics |
|
| SC ABT-308 in asthmatics | Experimental | ABT-308 multiple SQ doses in mild to moderate asthmatics |
|
| IV ABT-308 in healthy volunteers | Experimental | ABT-308 single escalating IV doses in healthy volunteers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-308 | Drug | Single IV doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments. | 12 weeks after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics will be determined by measuring serum concentration of ABT-308. | 12 weeks after last dose | |
| Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies. | 12 weeks after last dose |
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Inclusion Criteria:
Healthy volunteers:
Mild asthma patients:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Campbell, MD | Abbott | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28455782 | Result | Tripp CS, Cuff C, Campbell AL, Hendrickson BA, Voss J, Melim T, Wu C, Cherniack AD, Kim K. RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 alpha1 and alpha2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study. Adv Ther. 2017 Jun;34(6):1364-1381. doi: 10.1007/s12325-017-0525-8. Epub 2017 Apr 28. |
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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 |
|---|---|
| C000625155 | cendakimab |
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| ABT-308 |
| Drug |
Multiple SC doses x 3 |
|
| Placebo | Drug | Single IV dose |
|
| Placebo | Drug | Multiple SC doses x 3 |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |