A Study to Assess the Efficacy and Safety of Vutiglabridin in Early Parkinson's Disease Patients - Trial NCT06329141

Timeline & Enrollment

Primary Outcome

Change From Baseline in MDS-UPDRS Part III Subscore

Summary

1. Study Objective
 
 - To assess the efficacy and safety of vutiglabridin in early Parkindson's disease
 patients
 
 2. Background Glaceum Inc. has evaluated the safety, tolerability, and
 pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through
 its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the
 efficacy and safety of vutiglabridin in early Parkinson's disease patients.
 
 3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled,
 parallel-group trial. Subjects deemed eligible to participate in this study based on the
 inclusion/exclusion criteria will be assigned a subject number and randomized to one of
 the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will
 be randomized to double-blind treatments and will receive a once-daily oral dose of the
 investigational product for 24 weeks according to the study protocol. Several parameters
 (i.e., MDS-UPDRS, CGI-C, K-NMSS, modified Hoehn-Yahr stage and SNBR) will be evaluated
 to assess the efficacy of vutiglabridin. Assessments including measurement of vital
 signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and
 adverse event monitoring will be performed to evaluate the safety and tolerability of
 vutiglabridin. Blood samples will be collected for pharmacokinetic assessment.

ICD-10 Classifications