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

NCT ID: NCT05296083

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-17
• Study Completion Date: 2022-05-25

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

G3P-01 50mg Dose Treatment Period 1

G3P-01 will be administered orally as a powdered mixed with water. Treatment Period one dose will be 50mg of IP.

Group Type: EXPERIMENTAL

G3P-01

Intervention Type: DIETARY_SUPPLEMENT

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

G3P-01 500mg Dose Treatment Period 2

G3P-01 will be administered orally as a powdered mixed with water. Treatment Period two dose will be 500mg of IP.

Group Type: EXPERIMENTAL

G3P-01

Intervention Type: DIETARY_SUPPLEMENT

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

G3P-01 1000mg Dose Treatment Period 3

G3P-01 will be administered orally as a powdered mixed with water. Treatment Period three dose will be 1000mg of IP.

Group Type: EXPERIMENTAL

G3P-01

Intervention Type: DIETARY_SUPPLEMENT

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

G3P-01 2000mg Dose Treatment Period 4

G3P-01 will be administered orally as a powdered mixed with water. Treatment Period four dose will be 2000mg of IP.

Group Type: EXPERIMENTAL

G3P-01

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

G3P-01

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

1. Male or female, aged ≥ 18 to < 65 years;

2. Healthy volunteers, as determined by a comprehensive clinical assessment performed at screening (medical history, vital signs, clinical laboratory testing, ECG, and general physical examination);

3. Maintains a regular (mixed or vegetarian/vegan) diet.

4. Non-pregnant, non-lactating females who are either post-menopausal (natural or surgical) or are using at least one (1) of the following forms of contraception:

• Intrauterine device (IUD),
• Implantable progestogen-only hormone contraception associated with inhibition of ovulation,
• Intrauterine hormone-releasing system (IUS),
• Bilateral tubal occlusion
• Vasectomized partner
• Male or female condom with or without spermicide,
• Cervical cap, diaphragm, or sponge with spermicide,
• A combination of male condoms with either cervical cap, diaphragm, or sponge with spermicide (double-barrier methods)
• Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation

• oral
• intravaginal
• transdermal
• injectable
• Progestogen-only hormone contraception associated with inhibition of ovulation

• oral
• injectable
• Abstinence;

5. Willing to adhere to the prohibitions and restrictions specified in the protocol;

6. Must be competent to understand the nature of the study and capable of giving written informed consent and be willing to report for the scheduled study visits and communicate to study personnel about adverse events and concomitant medication use.

Exclusion Criteria

1. History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator;

2. Clinically significant abnormal laboratory test values at screening, as determined by the Investigator;

3. Any surgical or medical condition, which in the opinion of the Investigator may pose an undue risk to the subject, interfere with participation in the study, or which may affect the integrity of the study data.

4. Any positive urine drug screen or alcohol test at Screening or clinic admission.

5. Concomitant use of any drugs known to interact with oral absorption or metabolism of pharmaceuticals, including known inducers or inhibitors of cytochrome p450 enzyme system.

6. History of alcohol abuse within 6 months prior to Screening and/or signs or symptoms of alcoholism, as determined by the Investigator.

7. Positive test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV);

8. Participation in another clinical trial of an investigational drug (or medical device), or food supplement within 30 days prior to screening, or currently participating in another trial of an investigational drug (or medical device), or food supplement;

9. Donation of greater than 100 mL of either whole blood or plasma within 30 days prior to investigational product administration.

10. Been informed of possible COVID-19 exposure in past 4 weeks, or recent onset of signs or symptoms of possible COVID-19 infection, including cough, shortness of breath, or temperature ≥ 38°C.

11. Traveled via airplane or cruise ship within the last 14 days

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EB Medical Research

UNKNOWN

Sponsor Role: collaborator

Quartesian

UNKNOWN

Sponsor Role: collaborator

SQ Innovation, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mazin AlHakim, MD

Role: PRINCIPAL_INVESTIGATOR

EB FlevoResearch

Locations

EB FlevoResearch

Almere Stad, Flevoland, Netherlands

Countries

Netherlands

Other Identifiers

NL80001.028.21

Identifier Type: OTHER

Identifier Source: secondary_id

G3P-01-01

Identifier Type: -

Identifier Source: org_study_id