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The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.
As the TT-113 has been cleared for use as a topical hemostatic agent, the proposed study will further investigate the safety, tolerability and efficacy of TT-113 in healthy volunteers after tooth extraction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| TT-173 | Experimental | TT-173 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | It is applied directly to the bleeding site after tooth extraction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, Tmax, AUC and bioavailability | 48 h | |
| Determine the presence of coagulation disorders | Blood platelets, Prothrombin time, Fibrinogen, Thrombin time | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thrombotargets Europe SL | Castelldefels | Barcelona | 08860 | Spain |
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| Label | URL |
|---|---|
| Related Info | View source |
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| TT-173 |
| Drug |
It is applied directly to the bleeding site after tooth extraction |
|
| Determine the immune responses to TT-173 | Antibody concentration | 4 months |
| Time to hemostasis until cessation of bleeding | time 0 until cessation of bleeding |