Healthy Subjects Clinical Trial
Official title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP015K Following Single Oral Doses to Healthy Volunteers
The objective of the study is to explore safety and tolerability of single ascending doses of ASP015K, establish the maximum tolerated dose, and determine the pharmacokinetics and pharmacodynamics in healthy volunteers.
Subjects will be confined to the clinical research unit for five days. Some subjects will
participate in two confinement periods. Subjects will receive a follow-up phone call to
assess safety seven days after the administration of the single dose of study drug.
Subjects will be assigned to one of nine sequential groups A, B, C, D, E, F, G, H, or I. In
each group, 6 subjects will be randomized to ASP015K and 2 subjects will be randomized to
placebo. Subjects in group F will participate in two treatment periods. Subjects in the
first treatment period of group F will have a single study drug dose administered in the
fasted state. Subjects in the second treatment period of group F will have a single study
drug dose administered immediately following a standard FDA recommended high-fat breakfast.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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