Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer

NCT03001544 | Unknown Phase 1

• 1 other identifier: TS CP01-2015
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse events post-dose

  To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose

  10 weeks

Secondary Outcomes (6)

• Coagulation (fibrinogen, PT, aPTT)

  10 weeks

• Anti-drug antibody

  16 weeks

• alpha2-antiplasmin activity

  10 weeks

• D-dimer

  10 weeks

• Pharmacokinetic parameter, maximum concentration of TS23

  10 weeks

Study Arms (1)

Experimental Ascending Dose Cohort

EXPERIMENTAL

TS23

Biological: TS23

Interventions

TS23 BIOLOGICAL

comparison of different doses

Experimental Ascending Dose Cohort

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Translational Sciences, Inc.: lead

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: December 23, 2016
• Study Start: July 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: December 23, 2016

Record last verified: 2016-12