121
Participants
Start Date
February 27, 2018
Primary Completion Date
November 14, 2019
Study Completion Date
November 14, 2019
K-755 Part A (SAD)
Single ascending dose (SAD). There will be 7 cohorts in the Part A. Three quarters of subjects will receive K-755 tablet orally in a double-blind fashion.
Placebo Part A (SAD)
Single ascending dose (SAD). In Part A, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.
K-755 Part B (MAD)
Multiple ascending dose (MAD). There will be 4 cohorts in the Part B. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.
Placebo Part B (MAD)
Multiple ascending dose (MAD). In Part B, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.
K-755 Part C (FE)
Food effect (FE). All subjects in Part C will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.
K-755 Part D (FE)
Food effect (FE). All subjects in Part D will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.
K-755 Part E (MAD)
Multiple ascending dose (MAD). There will be 2 cohorts in the Part E. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.
Placebo Part E (MAD)
Multiple ascending dose (MAD). In the Part E. One quarter of subjects will receive placebo tablet orally in a double-blind fashion.
CMAX, Clinical Research Pty Ltd, Adelaide
Kowa Company, Ltd.
INDUSTRY