The purpose of this study is to evaluate the safety, tolerability and efficacy of TT-173 in healthy volunteers after tooth extraction.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Thrombotargets Europe SL
Castelldefels, Barcelona, Spain
Number of Adverse Events
Time frame: 4 months
Cmax, Tmax, AUC and bioavailability
Time frame: 48 h
Determine the presence of coagulation disorders
Blood platelets, Prothrombin time, Fibrinogen, Thrombin time
Time frame: 4 months
Determine the immune responses to TT-173
Antibody concentration
Time frame: 4 months
Time to hemostasis until cessation of bleeding
Time frame: time 0 until cessation of bleeding
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