Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer "TS23Phase1a"

Active, not recruiting

Phase 1 Results N/A

Trial Description

This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults.

Detailed Description

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.

Conditions

Interventions

  • TS23 Biological
    Intervention Desc: comparison of different doses
    ARM 1: Kind: Experimental
    Label: Experimental Ascending Dose Cohort
    Description: TS23

Outcomes

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 D-dimer 10 weeks
Secondary Pharmacokinetic parameter, maximum concentration of TS23 10 weeks
Secondary Pharmacokinetic parameter, half-life of TS23 10 weeks

Sponsors