healthy adult volunteers
Conditions
Interventions
Consists of 4 cohorts escalating from the first dose, each cohort will receive either TSP-101 or placebo.
Sponsors
Nakahara Takahito
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Provide written informed consent. 2. Healthy adult Japanese males aged 18 to = 50 kg and BMI >= 18 kg/m2 and < 25 kg/m2 at screening. 6. Agree that the subject and the subject's partner will use an appropriate method of contraception approved in Japan (including use of oral contraceptives, intrauterine device, and condom) from the time of screening until 1 day after study drug administration, and will not donate sperm. 7. Are capable of complying with the restrictions during their participation in the study, undergo the medical examinations and tests specified by the Protocol, and communicate sufficiently with the study personnel at the study site, including reporting of symptoms, etc.
Exclusion criteria
Exclusion criteria: 1. Any history of hypersensitivity to the Investigational Product, excipient of the Investigational Product, or other antibody drug product. 2. Investigational Product Any vitamins or supplements within 1 week prior to dosing and any over-the-counter or prescription medications within 2 weeks prior to dosing. 3. Any history of clinically significant disease or surgery, including infections, within 4 weeks prior to initiation of Investigational Product treatment 4. Any clinically significant medical anamnesis or complications, including neurologic, endocrine, cardiovascular, respiratory, hematologic, immune, psychiatric, gastrointestinal, renal, hepatic, metabolic, or inflammatory diseases. 5. Any anamnesis or comorbidity of liver disease or hepatic complications as indicated by abnormal liver function tests. 6. Anamnesis (within the last 12 months) or current history of drug or alcohol abuse. 7. Any strenuous exercise within 72 hours prior to admission to the study center. 8. Positive urine drug screen at screening and on Day-1. 9. Positive urine cotinine test at screening and on Day-1. 10. Positive alcohol breath test at screening and on Day-1. 11. Positive HBs antigen, HCV antibody, HIV antigen antibody, or syphilis test at screening. 12. Subject must have a systolic blood pressure of >= 140 mmHg or = 90 mmHg or 1.2 x upper limit of normal at screening and > 1.2 x upper limit of normal at re-examination. Other exclusion criteria 14. Are participating in another clinical study at the time of informed consent. Or, less than 16 weeks (12 weeks for generic clinical studies) or 5 half-lives (whichever is longer) between the start of treatment with the investigational product and the start of treatment with the investigational product. 15. Investigational Product Any subject with blood draw or blood loss of 400 mL or more within 12 weeks prior to dosing, blood draw of 200 mL or more within 4 weeks prior to dosing, or blood components donation within 2 weeks prior to dosing. 16. Are persons determined by the investigator to be unsuitable for any other reason for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse event and serious adverse event and severity of adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PK parameters of plasma TSP-101 (AUClast, AUCinf, Cmax, tmax, Elimination half-life, Vz, CL) 2. Receptor occupancy 3. Incidence of anti-drug antibody | — |
Contacts
Public ContactYuji Saita
Tensegrity Pharma Co., Ltd.
Outcome results
None listed