NCT04818398

Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects

Single-Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-6016a After Subcutaneous Injection in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after subcutaneous injection in healthy Japanese participants.

Conditions

• Fibrodysplasia Ossificans Progressiva

Interventions

Type	Name	Description
DRUG	DS-6016a	DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall
DRUG	Placebo	Placebo will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-12-24
• Completion: 2022-07-26
• First posted: 2021-03-26
• Last updated: 2022-08-03

Locations

1 site across 1 country: Japan