Testing Experimental Medication in Healthy Subjects
common.study.values.description
“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.
common.study.values.location
participant.ui.study.affiliations-map.online-study.header-virtual
participant.ui.study.affiliations-map.online-study.text
common.study.values.methods
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
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
participant.views.study.view.additional
participant.views.study.view.scientific-title
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
common.study.values.clinical-trial-id
NCT04104399
participant.views.study.view.id
eVORMa
