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.

NCT04104399

Conditions

1. Migraine

Interventions

1. Drug: XC101-D13H
2. Drug: Placebo

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. --- D13H ---

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. --- D13H ---

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. --- D13H ---

Adverse Events will be monitored throughout confinement in the clinic and through the 14-day follow-up visit.. Maximum plasma concentration [Cmax] of XC101-D13H. --- D13H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the maximum observed concentration for XC101-D13H will be calculated.. Area under the curve [AUC] of XC101-D13H. --- D13H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the maximum observed concentration for XC101-D13H will be calculated.. Area under the curve [AUC] of XC101-D13H. --- D13H --- --- D13H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the area under the concentration-time curve, from time 0 to the last observed non-zero concentration will be calculated for XC101-D13H.. Time to reach maximum plasma concentration [Tmax] of XC101-D13H. --- D13H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the area under the concentration-time curve, from time 0 to the last observed non-zero concentration will be calculated for XC101-D13H.. Time to reach maximum plasma concentration [Tmax] of XC101-D13H. --- D13H --- --- D13H ---

Blood samples will be collected pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, and 48 hours post-dose and the time to reach the maximum plasma concentration of XC101-D13H will be calculated.. Major Inclusion Criteria: - Healthy, adult, male or female of non childbearing potential only, 18-55 years of age, inclusive, at screening. --- D13H ---