Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer (TS23Phase1a)

Translational Sciences, Inc.

Status and phase

Unknown

Phase 1

Conditions

Pulmonary Embolism

Cerebral Ischemia

Thrombosis

Myocardial Infarction

Venous Thrombosis

Treatments

Biological: TS23

Study type

Interventional

Funder types

Industry

Identifiers

NCT03001544

TS CP01-2015

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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)
Any previous or current monoclonal antibody therapy
History of trauma or surgery within the past 60 days or planned surgery within 30 days
Abnormal baseline laboratory values or any laboratory values deemed clinically significant by the Investigator
Recent history of head trauma in last 30 days prior to receiving TS23
Unwillingness or inability to avoid contact sports or other activities with more than a small risk of head or facial trauma within 30 days of receiving TS23
History of or risk of falls (e.g., due to dementia, frailty, etc.)
Sexually active subjects must agree to use a reliable method of birth control (abstinence, condoms, vasectomy) and to not donate sperm for 3 months after receiving TS23