Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer

Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03001544
• Other study ID #: TS CP01-2015
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 11, 2016
• Last updated: December 20, 2016
• Start date: July 2015
• Est. completion date: June 2017

Study information

• Verified date: December 2016
• Source: Translational Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Embolism
• Infarction
• Ischemia
• Myocardial Infarction
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Biological:
• TS23
comparison of different doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Translational Sciences, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Coagulation (fibrinogen, PT, aPTT)		10 weeks	Yes
Secondary	Anti-drug antibody		16 weeks	Yes
Secondary	alpha2-antiplasmin activity		10 weeks	No
Secondary	D-dimer		10 weeks	No
Secondary	Pharmacokinetic parameter, maximum concentration of TS23	Pharmacokinetic parameter Cmax of TS23 in plasma	10 weeks	No
Secondary	Pharmacokinetic parameter, half-life of TS23	Pharmacokinetic parameter, time required for TS23 concentrations to fall by half	10 weeks	No