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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507611-35-00 | EU Trial (CTIS) Number | ||
| 1008606 | Registry Identifier | Integrated Research Application System (IRAS) |
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This study is testing the safety, tolerability, pharmacokinetics and pharmacodynamics of GB-0895.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Ascending Dose (SAD) (asthma participants) | Experimental | randomized 3:1 active:placebo |
|
| Part B: Multiple Ascending Dose (MAD) (asthma participants) | Experimental | randomized 3:1 active:placebo |
|
| Part C: Single Dose (COPD participants) | Experimental | randomized 3:1 active:placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB-0895 (SC) | Biological | Single subcutaneous dose of GB-0895 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment related adverse events as assessed by CTCAE 5.0 | Day 1 to Day 500 |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of maximum plasma concentration of GB-0895 | Day 1 to Day 500 | |
| Total exposure of GB-0895 (AUC) | Day 1 to Day 500 | |
| Blood eosinophil counts |
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Inclusion Criteria (Part A & B, Asthma):
Exclusion Criteria (Part A & B, Asthma):
Inclusion Criteria (Part C, COPD):
Exclusion Criteria (Part C, COPD):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcanza | DeLand | Florida | 32720 | United States | ||
| Miami Research Institute of South Florida |
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| GB-0895 (SC) | Biological | Multiple subcutaneous doses of GB-0895 |
|
| Placebo (SC) | Drug | Single subcutaneous dose of placebo |
|
| Placebo (SC) | Drug | Multiple subcutaneous doses of placebo |
|
| Day 1 to Day 500 |
| Incidence of treatment-emergent anti-drug antibody (ADA) response | Day 1 to Day 500 |
| Miami |
| Florida |
| 33173 |
| United States |
| Omega Research | Orlando | Florida | 32808 | United States |
| Nucleus Network | Saint Paul | Minnesota | 55114 | United States |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Charite Research Organization GmbH | Berlin | Germany |
| IKF Pneumologie | Frankfurt | Germany |
| Fraunhofer Institut fur Toxikologie and Experimentelle Medizin (ITEM) | Hanover | Germany |
| Hammersmith Medicines Research | London | United Kingdom |
| Queen Anne Street Medical Center | London | United Kingdom |
| Medicines Evaluation Unit (MEU) | Manchester | United Kingdom |
| Simbec-Orion Clinical Development | Merthyr Tydfil | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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