NCT05238701

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

A Randomized, Double-blinded, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 Sustained-release Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-02-25
• Primary completion: 2023-11-04
• Completion: 2023-11-04
• First posted: 2022-02-14
• Last updated: 2024-01-29

Locations

1 site across 1 country: China