Safety, Tolerability and Efficacy Study of TT-173 in Healthy Volunteers After Tooth Extraction
NCT ID: NCT01595360
Last Updated: 2013-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2012-04-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Placebo
Placebo
Placebo
It is applied directly to the bleeding site after tooth extraction
TT-173
TT-173
TT-173
It is applied directly to the bleeding site after tooth extraction
Interventions
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Placebo
It is applied directly to the bleeding site after tooth extraction
TT-173
It is applied directly to the bleeding site after tooth extraction
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Thrombotargets Europe S.L
INDUSTRY
Responsible Party
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Locations
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Thrombotargets Europe SL
Castelldefels, Barcelona, Spain
Countries
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Related Links
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Related Info
Other Identifiers
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2010-021882-57
Identifier Type: -
Identifier Source: org_study_id