Healthy Clinical Trial
Official title:
Phase I Study of ASP2408 -Subcutaneous Single-dose, Placebo-controlled Study in Non-elderly Healthy Adult Male Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single subcutaneous dose of ASP2408 in non-elderly healthy adult male subjects. The pharmacodynamics of ASP2408 is also being evaluated.
This clinical study will be conducted as a double-blind, placebo-controlled, single
ascending subcutaneous dose study. As shown in the table below, the study will be conducted
using 3 cohorts, to which a total of 24 subjects will be randomly assigned (18 subjects
receiving ASP2408 and 6 subjects receiving placebo). Each cohort will consist of 8 subjects,
who will be randomly assigned to either the ASP2408 group or the placebo group at the ratio
of 3 to 1.
Each subject will need to be hospitalized until Day 8 (start date of study drug
administration will be regarded as Day 1) and will be observed until Day 90. The
investigator or subinvestigator will carefully observe each subject for any sign or symptom
of adverse events.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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