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A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects

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Astellas

Status and phase

Completed
Phase 1

Conditions

Healthy
Pharmacokinetics of ASP0456

Treatments

Drug: ASP0456
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01279915
0456-CL-0011

Details and patient eligibility

About

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

Enrollment

32 patients

Sex

Male

Ages

20 to 44 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

32 participants in 2 patient groups, including a placebo group

ASP group
Experimental group
Description:
ASP0456 receiving group
Treatment:
Drug: ASP0456
Placebo group
Placebo Comparator group
Description:
Placebo treatment
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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