Testing Experimental Medication in Healthy Subjects
common.study.values.description
“Assess the Gluten Degradation Activity of PvP001 and PvP002 in Healthy Adult Volunteers and Adults With Celiac Disease”
This study has two parts. Each part of the study begins with a Screening Period of up to 4 weeks to allow for completion of screening procedures and subject scheduling. Each subject will be screened by means of medical history, medication review, Gastrointestinal Symptoms Questionnaire (GSQ), physical examination, vital signs, weight, height, laboratory tests, and ECG.
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
PvP001 placebo
placebo
Drug - PvP001 100 mg
PvP001 100 mg
Drug - PvP001 300 mg
PvP001 300 mg
Drug - PvP001 900 mg
PvP001 900 mg
Drug - Maximum Feasible Dose (MFD) of PvP002
Maximum Feasible Dose (MFD) of PvP002
Drug - Maximum Tolerated Dose (MTD) of PvP001
Maximum Tolerated Dose (MTD) of PvP001
Drug - MTD of PvP001 following 7 days of PPI treatment
Maximum Tolerated Dose (MTD) of PvP001 following 7 days of PPI (Proton Pump Inhibitor) treatment
PvP002 placebo
Placebo
Drug - PvP001 600 mg
PvP001 600 mg
participant.views.study.view.additional
participant.views.study.view.scientific-title
A Ph1, Two-Part Study to Assess the Safety, Tolerability, and Pk of PvP001 and PvP002 in Healthy Adult Volunteers and Adults With Celiac Disease and to Assess the Gluten Degradation Activity of PvP001 and PvP002 in Healthy Adult Volunteers
common.study.values.clinical-trial-id
NCT03701555
participant.views.study.view.id
azpXYd
