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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

NCT05296083 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-06-13

No results posted yet for this study

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

DIETARY_SUPPLEMENT

G3P-01

G3P-01 is a food-grade pectic product derived from squash.

Sponsors & Collaborators

  • EB Medical Research

    collaborator UNKNOWN

  • Quartesian

    collaborator UNKNOWN

  • SQ Innovation, Inc.

    lead INDUSTRY

Principal Investigators

  • Mazin AlHakim, MD · EB FlevoResearch

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-17
Primary Completion
2022-05-25
Completion
2022-05-25

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05296083 on ClinicalTrials.gov