Clinical Drug Experience Knowledgebase

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