NCT03830528

A Study of Single and Multiple Doses of KW-6356 in Healthy Subjects

A Phase I Study of KW-6356 in Japanese and Caucasian Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Kyowa Kirin Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers

Detailed description

The study will have 3 parts: * In Part A and Part B, a placebo-controlled double-blind study will be conducted to investigate safety, tolerability and pharmacokinetics of a single dose and 14 days multiple doses of KW-6356 in Japanese healthy men, respectively * In Part C, an open-label study will be conducted to investigate safety, tolerability and pharmacokinetics of 7 days multiple doses of KW-6356 in Japanese and Caucasian healthy men

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	KW-6356 Low Dose	KW-6356 will be administered as single doses.
DRUG	KW-6356 Middle Dose	KW-6356 will be administered as single doses.
DRUG	KW-6356 High Dose	KW-6356 will be administered as single doses.
DRUG	KW-6356 X Dose	KW-6356 will be administered as multiple doses.
DRUG	KW-6356 Y Dose	KW-6356 will be administered for Japanese healthy men as multiple doses.
DRUG	Placebo	All study cohorts (except Part C) are placebo controlled.

Timeline

• Start date: 2019-02-26
• Primary completion: 2019-10-10
• Completion: 2019-10-10
• First posted: 2019-02-05
• Last updated: 2019-11-29

Locations

1 site across 1 country: Japan