Clincosm LogoSign in Get a demo

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

Sponsor
Thrombotargets Europe S.L (Industry)
Overall Status
Completed
CT.gov ID
NCT01595360
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
17
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Randomized, Open, Controlled, Comparative Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo

Drug: Placebo
It is applied directly to the bleeding site after tooth extraction
Experimental: TT-173

TT-173

Drug: TT-173
It is applied directly to the bleeding site after tooth extraction

Outcome Measures

Primary Outcome Measures

  1. Number of Adverse Events [4 months]

Secondary Outcome Measures

  1. Cmax, Tmax, AUC and bioavailability [48 h]

  2. Determine the presence of coagulation disorders [4 months]

    Blood platelets, Prothrombin time, Fibrinogen, Thrombin time

  3. Determine the immune responses to TT-173 [4 months]

    Antibody concentration

  4. Time to hemostasis until cessation of bleeding [time 0 until cessation of bleeding]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thrombotargets Europe SL Castelldefels Barcelona Spain 08860

Sponsors and Collaborators

  • Thrombotargets Europe S.L

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Thrombotargets Europe S.L
ClinicalTrials.gov Identifier:
NCT01595360
Other Study ID Numbers:
  • 2010-021882-57
First Posted:
May 10, 2012
Last Update Posted:
Sep 16, 2013
Last Verified:
Sep 1, 2013
Keywords provided by Thrombotargets Europe S.L
TT-173
Topical Hemostatics
Hemostasis

Study Results

No Results Posted as of Sep 16, 2013