Cerebral Ischemia, Myocardial Infarction, Pulmonary Embolism, Thrombosis, Venous Thrombosis
Conditions
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.
Interventions
BIOLOGICALTS23
comparison of different doses
Sponsors
Translational Sciences, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and severity of adverse events post-dose | 10 weeks | To count the number and assess the severity of treatment emergent adverse events within 10 weeks post dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-drug antibody | 16 weeks | — |
| alpha2-antiplasmin activity | 10 weeks | — |
| Coagulation (fibrinogen, PT, aPTT) | 10 weeks | — |
| Pharmacokinetic parameter, maximum concentration of TS23 | 10 weeks | Pharmacokinetic parameter Cmax of TS23 in plasma |
| Pharmacokinetic parameter, half-life of TS23 | 10 weeks | Pharmacokinetic parameter, time required for TS23 concentrations to fall by half |
| D-dimer | 10 weeks | — |
Outcome results
None listed