Study of Safety and Biomarker Efficacy of TS23 in Healthy Volunteer "TS23Phase1a"

Active, not recruiting

Phase 1 Results N/A

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