Clinical Trial

Testing Experimental Medication in Healthy Subjects

Study 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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

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

Additional Information

Official Study 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

Clinical Trial ID

NCT03701555

ParticipAid ID

azpXYd