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.
- TS23 Biological
Intervention Desc: comparison of different doses ARM 1: Kind: Experimental Label: Experimental Ascending Dose Cohort Description: TS23
|Type||Measure||Time Frame||Safety Issue|
|Primary||Number and severity of adverse events post-dose||10 weeks|
|Secondary||Coagulation (fibrinogen, PT, aPTT)||10 weeks|
|Secondary||Anti-drug antibody||16 weeks|
|Secondary||alpha2-antiplasmin activity||10 weeks|
|Secondary||Pharmacokinetic parameter, maximum concentration of TS23||10 weeks|
|Secondary||Pharmacokinetic parameter, half-life of TS23||10 weeks|