Clinical trial NCT03001544: Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer
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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Thrombosis
Cerebral Ischemia
Venous Thrombosis
Pulmonary Embolism
Myocardial Infarction
Lead sponsor: Translational Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2016-12-23
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number and severity of adverse events post-dose
timeFrame: 10 weeks
Secondary outcomes:
measure: Coagulation (fibrinogen, PT, aPTT)
timeFrame: 10 weeks
measure: Anti-drug antibody
timeFrame: 16 weeks
measure: alpha2-antiplasmin activity
timeFrame: 10 weeks
measure: D-dimer
timeFrame: 10 weeks
measure: Pharmacokinetic parameter, maximum concentration of TS23
timeFrame: 10 weeks
measure: Pharmacokinetic parameter, half-life of TS23
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
References: