A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

Phase I Study of ASP0456 - A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Non-elderly Healthy Male Subjects

A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.

Inclusion Criteria:

• Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
• Body weight (at screening); ≥50.0 kg,<80.0 kg
• BMI(at screening): ≥17.6,<26.4

Exclusion Criteria:

• Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
• Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
• Received medication within 10 days before dose is administered or is scheduled to receive medication
• History of drug allergies
• Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
• Concurrent or previous hepatic disease
• Concurrent or previous heart disease
• Concurrent or previous renal disease