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

Neurological Disorder Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05938452
Study type Interventional
Source Forest Hills Lab
Contact
Status Completed
Phase Phase 1
Start date December 12, 2022
Completion date October 19, 2023
View Details
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