NCT03001544

Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer

Phase 1 Single-ascending Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Anti-alpha2-antiplasmin (α2AP) Monoclonal Antibody TS23 in Healthy Human Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Translational Sciences, Inc. · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

• Thrombosis
• Cerebral Ischemia
• Venous Thrombosis
• Pulmonary Embolism
• Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	TS23	comparison of different doses

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-06-01
• Completion: 2017-06-01
• First posted: 2016-12-23
• Last updated: 2016-12-23