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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
G3P-01 is a food-grade pectic product derived from squash.
EB FlevoResearch
Almere Stad, Flevoland, Netherlands
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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,
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, up to 70 days
Pharmacokinetic parameters- Cmax
Subject to the development of suitable analytical methods, maximum plasma concentration will be determined.
Time frame: Up to 3 years
Pharmacokinetic parameters- Tmax
Subject to the development of suitable analytical methods, time corresponding to the Cmax will be determined.
Time frame: Up to 3 years
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.
Time frame: Up to 3 years
Pharmacokinetic parameters- T1/2/ el
Subject to the development of suitable analytical methods, elimination half-life will be determined.
Time frame: Up to 3 years
Pharmacokinetic parameters- Vd
Subject to the development of suitable analytical methods, volume distribution will be determined.
Time frame: Up to 3 years
Pharmacokinetic parameters- Clr
Subject to the development of suitable analytical methods, renal clearance will be determined.
Time frame: Up to 3 years
Pharmacokinetic parameters- dose proportionality
Subject to the development of suitable analytical methods, dose proportionality will be determined.
Time frame: Up to 3 years
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