A Safety/Tolerance Phase, Ascending Single Dose Study to Evaluate the Safety and Tolerability of G3P-01, a Food-Grade Pectic Product, in Healthy Volunteers — G3P-01-01  

Gastrointestinal Discomfort Clinical Trial

Official title: A Safety/Tolerance Phase, Ascending Single Dose Study to Evaluate the Safety and Tolerability of G3P-01, a Food-Grade Pectic Product, in Healthy Volunteers

Status Completed

Clinical Trial Summary

This is an interventional, open-label study to evaluate the safety, tolerability and PK of escalating single doses of G3P-01 in 10 healthy adult subjects. All participants will receive G3P-01 in sequential, escalating doses of 50mg (Period 1), 500mg (Period 2), 1,000mg (Period 3), and 2,000mg (Period 4). A wash out period of at least 7 days will occur between doses in each sequential treatment period. Subjects will be admitted Day 1 and stay overnight until the morning of Day 2 for each treatment period. There will be a follow up call 14 days (+/- 2 days) following the last dose of the IP.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Gastrointestinal Discomfort
• Performance Status

• NCT number: NCT05296083
• Study type: Interventional
• Source: SQ Innovation, Inc.
• Status: Completed
• Phase: N/A
• Start date: March 17, 2022
• Completion date: May 25, 2022