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 | Completed

• 2 other identifiers: G3P-01-01NL80001.028.21
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Gastrointestinal; Performance

Outcome Measures

Primary Outcomes (11)

• Number, severity, and nature of adverse events following the administration of ascending doses of G3-P01

  Evaluating the safety of ascending doses of G3-P01 based on treatment related adverse events

  Through study completion, up to 70 days

• Clinical safety and laboratory parameters- Adverse Events

  Number of participants with treatment emergent adverse events. Measured by observation and reporting

  Through study completion, up to 70 days

• Clinical safety and laboratory parameters-Clinical Laboratory Results,hematology

  Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Hematology/Serum Chemistry.

  Through study completion, up to 70 days

• Clinical safety and laboratory parameters-Clinical Laboratory Results, urinalysis

  Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Urinalysis.

  Through study completion, up to 70 days

• Clinical safety and laboratory parameters-Clinical Laboratory Results, serology

  Number of participants with clinically significant change in clinical laboratory results reported as AEs. Measured by Serology,

  Through study completion, up to 70 days

• Clinical safety and laboratory parameters-Vital Signs, blood pressure

  Number of participants with clinically significant change in vital signs reported as AEs. Measured by BP

  Through study completion, up to 70 days

• Clinical safety and laboratory parameters-Vital Signs, pulse

  Number of participants with clinically significant change in vital signs reported as AEs. Measured by pulse.

  Through study completion, up to 70 days

• Clinical safety and laboratory parameters-Vital Signs, respiratory rate.

  Number of participants with clinically significant change in vital signs reported as AEs. Measured by respiratory rate.

  Through study completion, up to 70 days

• Clinical safety and laboratory parameters-Vital Signs, body temperature.

  Number of participants with clinically significant change in vital signs reported as AEs. Measured by body temperature.

  Through study completion, up to 70 days

• Change from baseline in tolerability assessment using Questionnaire

  Tolerability assessment using the Gastrointestinal Symptom Rating Scale (GSRS). There are 15 individual questions, each with a score of 1-7. Higher scores reflect a worse outcome.

  Through study completion, up to 70 days

• Change from baseline in performance status using Questionnaire

  Performance status assessment using the Karnofsky Performance Scale Index. The scale is 0-100, with 0 reflecting a worse outcome.

  Through study completion, up to 70 days

Secondary Outcomes (7)

• Pharmacokinetic parameters- Cmax

  Up to 3 years

• Pharmacokinetic parameters- Tmax

  Up to 3 years

• Pharmacokinetic parameters- AUC

  Up to 3 years

• Pharmacokinetic parameters- T1/2/ el

  Up to 3 years

• Pharmacokinetic parameters- Vd

  Up to 3 years

Study Arms (4)

G3P-01 50mg Dose Treatment Period 1

EXPERIMENTAL

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

Dietary Supplement: G3P-01

G3P-01 500mg Dose Treatment Period 2

EXPERIMENTAL

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

Dietary Supplement: G3P-01

G3P-01 1000mg Dose Treatment Period 3

EXPERIMENTAL

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

Dietary Supplement: G3P-01

G3P-01 2000mg Dose Treatment Period 4

EXPERIMENTAL

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

Dietary Supplement: G3P-01

Interventions

G3P-01 DIETARY_SUPPLEMENT

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

G3P-01 1000mg Dose Treatment Period 3; G3P-01 2000mg Dose Treatment Period 4; G3P-01 500mg Dose Treatment Period 2; G3P-01 50mg Dose Treatment Period 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged ≥ 18 to \< 65 years;
• Healthy volunteers, as determined by a comprehensive clinical assessment performed at screening (medical history, vital signs, clinical laboratory testing, ECG, and general physical examination);
• Maintains a regular (mixed or vegetarian/vegan) diet.
• 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

You may not qualify if:

• 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;
• Clinically significant abnormal laboratory test values at screening, as determined by the Investigator;
• 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.
• Any positive urine drug screen or alcohol test at Screening or clinic admission.
• 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.
• History of alcohol abuse within 6 months prior to Screening and/or signs or symptoms of alcoholism, as determined by the Investigator.
• Positive test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV);
• 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;
• Donation of greater than 100 mL of either whole blood or plasma within 30 days prior to investigational product administration.
• 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.
• Traveled via airplane or cruise ship within the last 14 days

Sponsors & Collaborators

• SQ Innovation, Inc.: lead
• EB Medical Research: collaborator
• Quartesian: collaborator

Study Sites (1)

EB FlevoResearch

Almere Stad, Flevoland, 1311 RL, Netherlands

Location

Study Officials

• Mazin AlHakim, MD

  EB FlevoResearch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 25, 2022
• Study Start: March 17, 2022
• Primary Completion: May 25, 2022
• Study Completion: May 25, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)