NCT05296083

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: SQ Innovation, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastrointestinal Discomfort
• Performance Status

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	G3P-01	G3P-01 is a food-grade pectic product derived from squash.

Timeline

• Start date: 2022-03-17
• Primary completion: 2022-05-25
• Completion: 2022-05-25
• First posted: 2022-03-25
• Last updated: 2022-06-13

Locations

1 site across 1 country: Netherlands