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

• ClinicalTrials.gov Identifier: NCT03001544
• Recruitment Status: Unknown
• First Posted: December 23, 2016
• Last Update Posted: December 23, 2016
• Sponsor: Translational Sciences, Inc.
• Information provided by (Responsible Party): Translational Sciences, Inc.

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Translational Sciences, Inc.
• ClinicalTrials.gov Identifier: NCT03001544
• Other Study ID Numbers: TS CP01-2015
• First Posted: December 23, 2016
• Last Update Posted: December 23, 2016
• Last Verified: December 2016

Additional relevant MeSH terms:

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