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

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ClinicalTrials.gov Identifier: NCT03001544
Recruitment Status : Unknown
Verified December 2016 by Translational Sciences, Inc..
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2016
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Translational Sciences, Inc.

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

Condition or disease Intervention/treatment Phase
Thrombosis Cerebral Ischemia Venous Thrombosis Pulmonary Embolism Myocardial Infarction Biological: TS23 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2015
Actual Primary Completion Date : June 2016
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: Experimental Ascending Dose Cohort
TS23
Biological: TS23
comparison of different doses




Primary Outcome Measures :
  1. Number and severity of adverse events post-dose [ Time Frame: 10 weeks ]
    To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose


Secondary Outcome Measures :
  1. Coagulation (fibrinogen, PT, aPTT) [ Time Frame: 10 weeks ]
  2. Anti-drug antibody [ Time Frame: 16 weeks ]
  3. alpha2-antiplasmin activity [ Time Frame: 10 weeks ]
  4. D-dimer [ Time Frame: 10 weeks ]
  5. Pharmacokinetic parameter, maximum concentration of TS23 [ Time Frame: 10 weeks ]
    Pharmacokinetic parameter Cmax of TS23 in plasma

  6. Pharmacokinetic parameter, half-life of TS23 [ Time Frame: 10 weeks ]
    Pharmacokinetic parameter, time required for TS23 concentrations to fall by half



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
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Responsible Party: Translational Sciences, Inc.
ClinicalTrials.gov Identifier: NCT03001544    
Other Study ID Numbers: TS CP01-2015
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Pulmonary Embolism
Brain Ischemia
Cerebral Infarction
Myocardial Infarction
Thrombosis
Embolism
Venous Thrombosis
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Infarction
Stroke