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| Name | Class |
|---|---|
| Novotech (Australia) Pty Limited | INDUSTRY |
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This is a Phase 1B study to assess the safety, tolerability and pharmacokinetics of DM199 in healthy volunteers. The study will be consist of two parts: Part A will focus on intravenous dosing and Part B will directly compare intravenous dosing with subcutaneous dosing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose (Part A) | Experimental | Recombinant human tissue kallikrein |
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| Medium low dose (Part A) | Experimental | Recombinant human tissue kallikrein |
|
| Medium high dose (Part A) | Experimental | Recombinant human tissue kallikrein |
|
| High dose (Part A) | Experimental | Recombinant human tissue kallikrein |
|
| Subcutaneous (Part B) | Experimental | Recombinant human tissue kallikrein |
|
| IV (Part B) | Experimental | Recombinant human tissue kallikrein |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human tissue kallikrein | Drug | Intravenous DM199 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Assessment of safety of intravenous dosing | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of DM199 in plasma | Assess plasma drug levels | 3 days |
| Concentration of bradykinin in plasma | Assess drug associated biomarkers (e.g. plasma bradykinin levels) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linear Clinical Research | Perth | Western Australia | Australia |
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| Label | URL |
|---|---|
| Safety, tolerability and pharmacokinetic profile of recombinant human tissue kallikrein, DM199, after intravenous and subcutaneous administration in healthy volunteers | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000726994 | DM199 |
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|
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| 3 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |