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

Thrombotargets

Status and phase

Completed

Phase 1

Conditions

Tooth Extraction

Treatments

Drug: Placebo

Drug: TT-173

Study type

Interventional

Funder types

Industry

Identifiers

NCT01595360

2010-021882-57

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.

Full description

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.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.