“Single Ascending Dose Study to Investigate the Safety and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects”
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. There are 4 cohorts of 8 subjects (8 active and 2 placebo) planned for evaluation under fasting conditions. One of the planned dose levels will cross over after a washout period to receive the same single dose of XC101-D13H or placebo under fed conditions.
Drug - XC101-D13H
XC101-D13H supplied as 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules
Drug - Placebo
Placebo supplied as matching capsules
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of XC101-D13H in Healthy Adult Subjects