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

Phase 1

Completed

• Conditions: Tooth Extraction
• Interventions: Drug: Placebo; Drug: TT-173

• Registration Number: NCT01595360
• Lead Sponsor: Thrombotargets Europe S.L

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-09
• Study First Posted: 2012-05-10
• Status Verified: 2013-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
TT-173	TT-173	TT-173

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	4 months

Secondary Outcome Measures

Name	Time	Method
Determine the immune responses to TT-173	4 months	Antibody concentration
Cmax, Tmax, AUC and bioavailability	48 h
Determine the presence of coagulation disorders	4 months	Blood platelets, Prothrombin time, Fibrinogen, Thrombin time
Time to hemostasis until cessation of bleeding	time 0 until cessation of bleeding

Trial Locations

Locations (1)

Thrombotargets Europe SL; 🇪🇸 Castelldefels, Barcelona, Spain