Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1617 in Healthy Adult Non-Asian and Japanese Subjects Including Assessment of a Food Effect
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 116
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
After a screening period of up to 28 days prior to study drug administration, eligible participants will be residential for a single period of 8 days/7 nights in Part 1: single ascending dose, and 21 days/20 nights in Part 2 multiple ascending dose.
After a screening period of up to 28 days prior to study drug administration, eligible participants will be residential for a single period of 8 days/7 nights in Part 1: single ascending dose, and 21 days/20 nights in Part 2 multiple ascending dose.
Tracking Information
- NCT #
- NCT04077879
- Collaborators
- Not Provided
- Investigators
- Study Director: Senior Director Astellas Pharma Global Development, Inc.