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

Gastrointestinal Discomfort Clinical Trial

— G3P-01-01  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296083
• Other study ID #: G3P-01-01
• Secondary ID: NL80001.028.21
• Status: Completed
• Phase: N/A
• Start date: March 17, 2022
• Est. completion date: May 25, 2022

Study information

• Verified date: June 2022
• Source: SQ Innovation, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Discomfort
• Performance Status

Intervention

Dietary Supplement:
• G3P-01
G3P-01 is a food-grade pectic product derived from squash.

Locations

Country	Name	City	State
Netherlands	EB FlevoResearch	Almere	Flevoland

Sponsors (3)

Lead Sponsor	Collaborator
SQ Innovation, Inc.	EB Medical Research, Quartesian

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Pharmacokinetic parameters- Cmax	Subject to the development of suitable analytical methods, maximum plasma concentration will be determined.	Up to 3 years
Secondary	Pharmacokinetic parameters- Tmax	Subject to the development of suitable analytical methods, time corresponding to the Cmax will be determined.	Up to 3 years
Secondary	Pharmacokinetic parameters- AUC	Subject to the development of suitable analytical methods, Area under the plasma concentration-time curve (AUC)" from time zero to the last non-zero concentration (AUC0-t), from time zero till 24-hours post-dose (AUC0-24), from time infinity (extrapolated) (AUC0-inf) will be determined.	Up to 3 years
Secondary	Pharmacokinetic parameters- T1/2/ el	Subject to the development of suitable analytical methods, elimination half-life will be determined.	Up to 3 years
Secondary	Pharmacokinetic parameters- Vd	Subject to the development of suitable analytical methods, volume distribution will be determined.	Up to 3 years
Secondary	Pharmacokinetic parameters- Clr	Subject to the development of suitable analytical methods, renal clearance will be determined.	Up to 3 years
Secondary	Pharmacokinetic parameters- dose proportionality	Subject to the development of suitable analytical methods, dose proportionality will be determined.	Up to 3 years