Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)

Phase I Clinical Study of TS-143 in Healthy Adult Male Subjects (Single-Dose Administration)

To investigate the safety, pharmacokinetics and pharmacodynamics when administering a single dose of TS-143 to Japanese healthy adult males using a placebo-controlled, double-blind, dose-ascending study, in addition to the effects of meals.

Inclusion Criteria:

1. Subjects with a body-mass index (BMI) of 18.5 to less than 25.0 at the time of the screening tests
2. Subjects judged by the principal investigator or a subinvestigator to be appropriate for participation in the study based on the results of the screening tests and the tests conducted prior to the investigational drug treatment

Exclusion Criteria:

1. Subjects who meet any of the following criteria in the screening tests or the tests conducted on Day -1 and prior to the investigational drug treatment

   • Red blood cell count: ≥ 535 × 10^4 /μL
   • Hemoglobin: ≥ 16.2 g/dL
   • Hematocrit: ≥ 47.5%
   • Reticulocyte ratio: Outside of the reference value range

2. Subjects who meet any of the following criteria in the screening tests

   • Serum EPO concentration: Outside of the reference value range
   • Ferritin: 30 ng/mL or less, or ≥ 262 ng/mL

3. Subjects who meet any of the following criteria in the vital signs in the screening tests and the tests conducted prior to the investigational drug treatment

   • Blood pressure: Systolic blood pressure ≥ 140 mmHg, or diastolic blood pressure ≥ 90 mmHg or more
   • Pulse rate: < 40 bpm, or ≥ 100 bpm
   • Body temperature: ≥ 37.5°C