Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Discomfort
Performance Status
Keywords: Gastrointestinal
Performance
Lead sponsor: SQ Innovation, Inc.
Sponsor class: INDUSTRY
Collaborators: name: EB Medical Research
name: Quartesian
First posted: 2022-03-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number, severity, and nature of adverse events following the administration of ascending doses of G3-P01
timeFrame: Through study completion, up to 70 days
measure: Clinical safety and laboratory parameters- Adverse Events
timeFrame: Through study completion, up to 70 days
measure: Clinical safety and laboratory parameters-Clinical Laboratory Results,hematology
timeFrame: Through study completion, up to 70 days
measure: Clinical safety and laboratory parameters-Clinical Laboratory Results, urinalysis
timeFrame: Through study completion, up to 70 days
measure: Clinical safety and laboratory parameters-Clinical Laboratory Results, serology
timeFrame: Through study completion, up to 70 days
measure: Clinical safety and laboratory parameters-Vital Signs, blood pressure
timeFrame: Through study completion, up to 70 days
measure: Clinical safety and laboratory parameters-Vital Signs, pulse
timeFrame: Through study completion, up to 70 days
measure: Clinical safety and laboratory parameters-Vital Signs, respiratory rate.
timeFrame: Through study completion, up to 70 days
measure: Clinical safety and laboratory parameters-Vital Signs, body temperature.
timeFrame: Through study completion, up to 70 days
measure: Change from baseline in tolerability assessment using Questionnaire
timeFrame: Through study completion, up to 70 days
measure: Change from baseline in performance status using Questionnaire
timeFrame: Through study completion, up to 70 days
Secondary outcomes:
measure: Pharmacokinetic parameters- Cmax
timeFrame: Up to 3 years
measure: Pharmacokinetic parameters- Tmax
timeFrame: Up to 3 years
measure: Pharmacokinetic parameters- AUC
timeFrame: Up to 3 years
measure: Pharmacokinetic parameters- T1/2/ el
timeFrame: Up to 3 years
measure: Pharmacokinetic parameters- Vd
timeFrame: Up to 3 years
measure: Pharmacokinetic parameters- Clr
timeFrame: Up to 3 years
measure: Pharmacokinetic parameters- dose proportionality
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: EB FlevoResearch
state: Flevoland
Study officials:
affiliation: EB FlevoResearch
name: Mazin AlHakim, MD
role: PRINCIPAL_INVESTIGATOR
References: