NCT07371065

To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Subjects

A Randomized, Double-blind, Dose-escalation Phase I Clinical Study to Evaluate the Safety, Tolerability, be Consistency and Food Effects of LY03021 Tablets in Healthy Subjects

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a multicenter, randomized withdrawal, double-blind, parallel, placebo-controlled design clinical trial of Toludesvenlafaxine Hydrochloride Extended-Release Tablets to evaluate the long-term efficacy and safety in the treatment of Chinese patients with depression.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	LY03021	Orally only once
DRUG	placebo	Orally only once

Timeline

• Start date: 2025-10-28
• Primary completion: 2026-04-30
• Completion: 2026-04-30
• First posted: 2026-01-27
• Last updated: 2026-01-27

Locations

1 site across 1 country: China