Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase 1, Randomized, Open, Controlled, Comparative Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction

Conditions
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Tooth Extraction

Intervention / Treatment
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* Drug: Placebo
* Drug: TT-173


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects to be undertaken for the simple extraction of at least one tooth (incisor, canine, premolar, molar different of third molar) that cause bloody wound, located in the upper or inferior maxillary area of the mouth either Subjects who are able and willing to provide written and signed informed consent All subjects willing to use a medically accepted form of contraception from the time of consent to completion of all follow-up study visits. Negative pregnancy test result in the screening visit. Exclusion Criteria: Subjects with personal and family history that could affect correct hemostasis Subjects with any clinically-significant coagulation disorder including including deficiencies in any of coagulation factors, thrombocytopenia and vascular purpura Subject with hipersensivity of TT-173 of any of its components or has a known allergy. Subjects who are unable to adequately follow or understand the instructions and requirements of the study. Subjects that are not fully free to give informed consent, or any other obstacle in the opinion of investigator support the conclusion that the subject is not fully reasoned.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* It is applied directly to the bleeding site after tooth extraction<br>|
| Experimental: TT-173<br>TT-173 | Drug: TT-173<br>* It is applied directly to the bleeding site after tooth extraction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Determine the immune responses to TT-173 | Antibody concentration | 4 months | 
| Time to hemostasis until cessation of bleeding |  | time 0 until cessation of bleeding | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TT-173, Topical Hemostatics, Hemostasis