This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults.
This is a first-in-human, Phase 1 study of the safety, pharmacokinetics and pharmacodynamics of TS23 in healthy male volunteers.TS23 is a monoclonal antibody that inactivates alpha 2-antiplasmin. Four dose cohorts of six subjects will be studied in a single ascending dose trial at one clinical center.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
comparison of different doses
Number and severity of adverse events post-dose
To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose
Time frame: 10 weeks
Coagulation (fibrinogen, PT, aPTT)
Time frame: 10 weeks
Anti-drug antibody
Time frame: 16 weeks
alpha2-antiplasmin activity
Time frame: 10 weeks
D-dimer
Time frame: 10 weeks
Pharmacokinetic parameter, maximum concentration of TS23
Pharmacokinetic parameter Cmax of TS23 in plasma
Time frame: 10 weeks
Pharmacokinetic parameter, half-life of TS23
Pharmacokinetic parameter, time required for TS23 concentrations to fall by half
Time frame: 10 weeks
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