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Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia

NCT06731868 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-22

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled parallel-group trial to evaluate the safety, tolerability, preliminary efficacy and PK characteristics of multiple doses of LPM3770164 sustained-release tablets in TD patients.

Conditions

  • Tardive Dyskinesia (TD)

Interventions

DRUG

LPM3770164 sustained release tablet 5 mg

LPM3770164 sustained release tablet once daily oral dosage at 5 mg for 6 weeks

DRUG

LPM3770164 sustained release tablet 10 mg

LPM3770164 sustained release tablet once daily oral dosage at 10 mg for 6 weeks.

DRUG

LPM3770164 sustained release tablet 20 mg

LPM3770164 sustained release tablet once daily oral dosage at 20 mg for 6 weeks.

DRUG

LPM3770164 sustained release tablet simulant

LPM3770164 sustained release tablet simulant once daily oral for 6 weeks.

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-14
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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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 NCT06731868 on ClinicalTrials.gov