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During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.
The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose level No.1 | Experimental | TPI ASM8 1 mg BID |
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| Dose level No.2 | Experimental | TPI ASM8 2 mg BID |
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| Dose level No.3 | Experimental | TPI ASM8 4mg BID |
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| Dose level No.4 | Experimental | TPI ASM8 8 mg Die |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPI ASM8 | Drug | 4 mg/mL, 1 mg BID for 4 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Sputum eosinophils (%) on Day 4 versus Screening for each dose level. | 7 and 24 hrs post-allergen challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability. | Throughout the study | |
| Plasma and sputum pharmacokinetic profile at the two highest dose levels. | Dose level 3 and 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rene Pageau, B.Pharm M.Sc | Topigen Pharmaceuticals Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McMaster University | Hamilton | Ontario | L8N 3Z5 | Canada |
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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 |
|---|---|
| C559988 | TPI ASM8 |
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| TPI ASM8 | Drug | 4 mg/mL, 2 mg BID for 4 days |
|
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| TPI ASM8 | Drug | 4 mg/mL, 4 mg BID for 4 days |
|
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| TPI ASM8 | Drug | 4 mg/mL, 8 mg OD for 4 days |
|
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |