NCT04963855

A Phase I Study of GT300 in Healthy Subjects

A Two-part, Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single Doses of GT300 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Generian Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Descriptive safety and pharmacokinetics of GT300, exploratory biomarker effects for the evaluation of the effect of GT300 on the autophagy-lysosomal pathway (ALP), food effect on PK and fasting effect on biomarkers.

Detailed description

This is a two-part study to be conducted under double-blind conditions. Part A will be conducted first and completed before Parts B is conducted. Part A is a single ascending dose evaluation of GT300 under double blind conditions in a population of healthy male and female subjects. Part B will be conducted once follow-up of the last cohort Part A has been conducted. On each study day in which drug is administered, dosing will be "staggered". Additionally, during Part A, a "sentinel" group comprising 1 active and 1 placebo subject will be dosed approximately 24 hours prior to dosing the remaining 6 subjects in group 1 (5 active, 1 placebo). Conduct of the study including clinical evaluation of subjects (up to the safety review meeting) will be under double-blind conditions. Progress from one cohort to the next will be contingent on satisfactory review of the safety and other data from each cohort. Part B is a single dose evaluation of the effect of food and prolonged fasting on the GT300 PK and biomarkers. The dose of GT300 will be equal to, or less than the maximum dose evaluated in Part A.

Conditions

• Lewy Body Disease

Interventions

Type	Name	Description
DRUG	GT300	SIngle oral dose
DRUG	Microcrystalline cellulose	placebo

Timeline

• Start date: 2021-08-23
• Primary completion: 2022-02-15
• Completion: 2022-03-15
• First posted: 2021-07-15
• Last updated: 2021-07-15