Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer

NCT ID: NCT03001544

Last Updated: 2016-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-06-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Ascending Dose Cohort

TS23

Group Type: EXPERIMENTAL

TS23

Intervention Type: BIOLOGICAL

comparison of different doses

Interventions

TS23

comparison of different doses

Intervention Type: BIOLOGICAL

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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Translational Sciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

TS CP01-2015

Identifier Type: -

Identifier Source: org_study_id