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

Translational Sciences, Inc.0 sites24 target enrollmentJuly 2015

ConditionsThrombosis Cerebral Ischemia Venous Thrombosis Pulmonary Embolism Myocardial Infarction

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Thrombosis
Sponsor: Translational Sciences, Inc.
Enrollment: 24
Primary Endpoint: Number and severity of adverse events post-dose
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

June 2017

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Translational Sciences, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to provide written informed consent
•Healthy males age 18 years to 60 years of age
•Body mass index ≥ 20 and ≤ 33 kg/m squared

Exclusion Criteria

•Known allergies or hypersensitivities to blood products or derivatives or therapeutic proteins or product excipients or components of CHO cells
•Current alcohol or drug abuse or history of alcohol or drug abuse
•Participation in any trial with an investigational drug within 90 days prior to dosing
•Blood donation of more than 500 mL of blood within 90 days prior to dosing
•Any history of a bleeding or thrombotic disorder
•Any history of significant cardiac, pulmonary, renal, hepatic, neurologic, or immunologic disorder
•Over-the-counter medications, dietary supplements and herbal products (except a daily vitamin) within 14 days of drug administration or during the study
•No prescription medication for at least 14 days or 5-half-lives, whichever is longer, prior to study drug administration.
•Use of anticoagulants, fibrinolytic agents or non-steroidal anti-inflammatory medicines (except aspirin doses of 82 mg per day or less) for 2 weeks prior to and during the study
•Known hereditary fructosemia (due to sorbitol in the formulation)