Testing Experimental Medication in Healthy Subjects
common.study.values.description
“Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult Subjects”
This is a randomized, double-blind, placebo-controlled, parallel-group single ascending dose (SAD) study. Up to 5 cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. In each cohort, subjects will receive a single oral dose of XC130-A10H or matching placebo on Day 1. Safety, tolerability, and pharmacokinetics will be assessed throughout the study. Dose escalation will not take place until the Principal Investigator, Sponsor, and Medical Monitor have determined that adequate safety and tolerability from the previous cohorts have been demonstrated to permit proceeding to the next cohort.
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.has-drugs-yes
                                 common.study.methods.is-healthy-no
                                        common.study.methods.is-healthy-no
                                Drug - XC130-A10H
XC130-A10H supplied as a 0.2, 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 Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult Subjects
common.study.values.clinical-trial-id
NCT04043338
participant.views.study.view.id
dR6qOd
 
    
    