Back to resultsStudy of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer (TS23Phase1a)
Primary Purpose
Thrombosis, Cerebral Ischemia, Venous Thrombosis
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
TS23
Sponsored by
About this trial
This is an interventional treatment trial for Thrombosis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Ascending Dose Cohort
Arm Description
TS23
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Coagulation (fibrinogen, PT, aPTT)
Anti-drug antibody
alpha2-antiplasmin activity
D-dimer
Pharmacokinetic parameter, maximum concentration of TS23
Pharmacokinetic parameter Cmax of TS23 in plasma
Pharmacokinetic parameter, half-life of TS23
Pharmacokinetic parameter, time required for TS23 concentrations to fall by half
Full Information
NCT ID
NCT03001544
First Posted
November 11, 2016
Last Updated
December 20, 2016
Sponsor
Translational Sciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03001544
Brief Title
Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer
Acronym
TS23Phase1a
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 Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Translational Sciences, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombosis, Cerebral Ischemia, Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Ascending Dose Cohort
Arm Type
Experimental
Arm Description
TS23
Intervention Type
Biological
Intervention Name(s)
TS23
Intervention Description
comparison of different doses
Primary Outcome Measure Information:
Title
Number and severity of adverse events post-dose
Description
To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Coagulation (fibrinogen, PT, aPTT)
Time Frame
10 weeks
Title
Anti-drug antibody
Time Frame
16 weeks
Title
alpha2-antiplasmin activity
Time Frame
10 weeks
Title
D-dimer
Time Frame
10 weeks
Title
Pharmacokinetic parameter, maximum concentration of TS23
Description
Pharmacokinetic parameter Cmax of TS23 in plasma
Time Frame
10 weeks
Title
Pharmacokinetic parameter, half-life of TS23
Description
Pharmacokinetic parameter, time required for TS23 concentrations to fall by half
Time Frame
10 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Learn more about this trial
Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer
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