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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE November 11, 2016
First Posted Date  ICMJE December 23, 2016
Last Update Posted Date December 23, 2016
Study Start Date  ICMJE July 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2016)
  • Coagulation (fibrinogen, PT, aPTT) [ Time Frame: 10 weeks ]
  • Anti-drug antibody [ Time Frame: 16 weeks ]
  • alpha2-antiplasmin activity [ Time Frame: 10 weeks ]
  • D-dimer [ Time Frame: 10 weeks ]
  • Pharmacokinetic parameter, maximum concentration of TS23 [ Time Frame: 10 weeks ]
    Pharmacokinetic parameter Cmax of TS23 in plasma
  • Pharmacokinetic parameter, half-life of TS23 [ Time Frame: 10 weeks ]
    Pharmacokinetic parameter, time required for TS23 concentrations to fall by half
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Thrombosis
  • Cerebral Ischemia
  • Venous Thrombosis
  • Pulmonary Embolism
  • Myocardial Infarction
Intervention  ICMJE Biological: TS23
comparison of different doses
Study Arms  ICMJE Experimental: Experimental Ascending Dose Cohort
TS23
Intervention: Biological: TS23
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: December 20, 2016)
24
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03001544
Other Study ID Numbers  ICMJE TS CP01-2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Translational Sciences, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Translational Sciences, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Translational Sciences, Inc.
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP