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A Phase I Study of GT300 in Healthy Subjects

NCT04963855 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-07-15

No results posted yet for this study

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.

Conditions

  • Lewy Body Disease

Interventions

DRUG

GT300

SIngle oral dose

DRUG

Microcrystalline cellulose

placebo

Sponsors & Collaborators

  • Generian Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2022-02-15
Completion
2022-03-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04963855 on ClinicalTrials.gov