MedTrace Logo

A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects

NCT05238701 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-01-29

No results posted yet for this study

Summary

This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation 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 subsequent clinical trials.

Conditions

  • Huntington Disease
  • Tardive Dyskinesia

Interventions

DRUG

LPM3770164 sustained release tablet

LPM3770164 sustained release tablet will be administrated orally single-dose on day 1

DRUG

LPM3770164 sustained release tablet simulant

LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Principal Investigators

  • hufang 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
2022-02-25
Primary Completion
2023-11-04
Completion
2023-11-04

Countries

  • China

Study Locations

More Related Trials

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 NCT05238701 on ClinicalTrials.gov