NCT06216054

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

A Randomized, Double-blind, Placebo-controlled, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 Sustained-release Tablets in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (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-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

Type	Name	Description
DRUG	LPM3770164 sustained release tablet	administrated orally
DRUG	LPM3770164 sustained release tablet simulant	administrated orally

Timeline

• Start date: 2023-12-19
• Primary completion: 2024-07-29
• Completion: 2024-07-29
• First posted: 2024-01-22
• Last updated: 2024-12-12

Locations

1 site across 1 country: China