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Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects

NCT06216054 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-12

No results posted yet for this study

Summary

This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy subjects under fasting state, providing the rationale information for later clinical trials.

Conditions

  • Tardive Dyskinesia
  • Huntington Disease

Interventions

DRUG

LPM3770164 sustained release tablet

administrated orally

DRUG

LPM3770164 sustained release tablet simulant

administrated orally

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • Huafang Li, Doctor · Shanghai Mental Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2024-07-29
Completion
2024-07-29

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 NCT06216054 on ClinicalTrials.gov