Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects

NCT05938452 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: FHL-101-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate) using a single ascending dose (SAD) study (under fasting conditions).

Conditions

Neurological Disorder

Outcome Measures

Primary Outcomes (6)

• Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events (TEAEs) until 30 days after the last administration of the study medication. 6\. Change from baseline in 12-lead electrocardiogram (ECG).

  7 days

• Treatment-Emergent Adverse Events Withdrawals

  Incidence of TEAEs leading to withdrawal of study drug or study discontinuation.

  7 days

• Laboratory Results

  Change from baseline in clinical laboratory results.

  7 days

• Physical Results

  Change from baseline in physical examination results

  7 days

• Vital Signs

  Change from baseline in vital signs.

  7 days

• Electrocardiogram

  Change from baseline in 12-lead electrocardiogram (ECG).

  7 days

Study Arms (2)

Active

EXPERIMENTAL

Active Comparator

Drug: Glyceryl Tribenzoate

Placebo

PLACEBO COMPARATOR

Placebo Comparator

Drug: Glyceryl Tribenzoate

Interventions

Glyceryl Tribenzoate DRUG

Oral Solution

Active; Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent prior to any study-related procedures.
• Male or female subjects 18 to 50 years of age inclusive.
• Subject's body mass index (BMI) is ≥ 18 kg/m2 and ≤ 30 kg/m2.
• Female subjects of childbearing potential must not be pregnant or lactating with a negative serum human chorionic gonadotropin (HCG) pregnancy test result at Screening, and negative urine pregnancy test on Day -1 (including Day -1 of Period 2 for SAD dosing participants i.e., fed cohort).
• Female subjects of childbearing potential must use an adequate method of contraception from Screening until 30 days after last dose of study medication. Acceptable methods of contraception are barrier methods (female condom, diaphragm, cervical cap, spermicide, or intrauterine device \[IUD\]), surgical sterility (self-reported: tubal ligation, hysterectomy, and/or bilateral oophorectomy), oral hormonal contraceptives, hormonal IUD, and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or subject report).
• Male subjects must use an adequate method of contraception from Screening until 30 days after last dose of study medication. Acceptable methods of contraception are barrier methods (condom), surgical sterility (self-reported), must also refrain from donating sperm while on study medication and until 30 days after last dose of study medication.
• Subject is in good health as determined by vital signs, medical history, physical exam, ECG, and safety laboratory analyses at Screening and during the study.
• Subject is negative for SARS-CoV-2 virus at admission Day -1 and Day 1 (during the SAD, Fed portion of the study, and MAD).
• Subject does not have dysphagia and discomfort with swallowing tablets/capsules.

You may not qualify if:

• Subject has used an investigational product or device within 30 days prior to enrollment or during the study.
• Subject has used prescription or non-prescription drugs (including vitamins, minerals, and herbal/plant-derived preparations) within 2 weeks of enrollment (excluding hormonal IUD, oral hormonal contraceptives, hormone replacement therapy, and acetaminophen) unless deemed acceptable by the Investigator in consultation with the Sponsor.
• Subject has a positive drug and/or alcohol test at Screening and on Day -1 (including 4. Day -1 of Period 2 for SAD dosing participants, i.e., fed cohort).
• Subject has a history of drug or alcohol abuse within 2 years before Screening.
• Subject is unable to abstain from ingesting alcohol or smoking for 72 hours prior to dosing and throughout the study.
• Concurrent use of probenecid, penicillin or other ß-lactams, or other drugs which undergo active tubular secretion in the kidneys.
• The subject has a clinically significant history of endocrinologic, hematologic, hepatic, immunologic, metabolic, cardiovascular, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major diseases or malignancy.
• Allergy to sodium benzoate.
• Has an active suicidal plan/intent or have had active suicidal thoughts in the past 6 months or a suicide attempt in the past 3 years.

Sponsors & Collaborators

• Forest Hills Lab: lead
• Liberyx Therapeutics Ltd.: collaborator

Study Sites (1)

TKL Research

Bloomfield, New Jersey, 07003, United States

Location

MeSH Terms

Conditions

Nervous System Diseases

Interventions

glyceryl tribenzoate

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 10, 2023
• Study Start: December 12, 2022
• Primary Completion: October 19, 2023
• Study Completion: October 19, 2023
• Last Updated: October 16, 2025

Record last verified: 2023-06

Locations

US (1)