Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
KW-6356 will be administered as single doses.
KW-6356 will be administered as single doses.
KW-6356 will be administered as single doses.
Medical Co. LTA Sumida Hospital
Tokyo, Japan
Part A Number and percentage of subjects with treatment-emergent adverse events
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part B Number and percentage of subjects with treatment-emergent adverse events
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part C Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part A Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part B Profiles of pharmacokinetics of plasma KW-6356 concentrations
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
Part C Number and percentage of subjects with treatment-emergent adverse events
Time frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
KW-6356 will be administered as multiple doses.
KW-6356 will be administered for Japanese healthy men as multiple doses.
All study cohorts (except Part C) are placebo controlled.