NCT05938452

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

A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study Followed by a Multiple-Dose Escalating Study of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Forest Hills Lab · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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).

Detailed description

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). After a wash out period, a cohort under fed conditions (ingestion of a high-fat morning meal) will be evaluated. Following the SAD, the multiple ascending dose phase will take place with two different cohorts. A battery of labs, hematology, physical examinations including vital signs, and ECGs will be monitored throughout the study for assessment of the study drug (GTB) compared with placebo. The clinical and laboratory data (excluding PK/PD data) of each cohort will be evaluated by a Data Monitoring Committee (DMC) to allow escalation to the next dose level during the SAD and MAD portions of the study.

Conditions

• Neurological Disorder

Interventions

Type	Name	Description
DRUG	Glyceryl Tribenzoate	Oral Solution

Timeline

• Start date: 2022-12-12
• Primary completion: 2023-10-19
• Completion: 2023-10-19
• First posted: 2023-07-10
• Last updated: 2025-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study