Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005

Major Depressive Disorder, Recurrent, Unspecified Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005

Status Completed

Clinical Trial Summary

Objectives

• To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in healthy subjects.

• To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.

Clinical Trial Description

This will be a randomized, double-blind, placebo-controlled, multiple ascending dose study to be conducted in the US. Approximately 48 healthy subjects will be enrolled into one of the four groups ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder, Recurrent, Unspecified
• Recurrence

• NCT number: NCT02271412
• Study type: Interventional
• Source: Luye Pharma Group Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: October 2014
• Completion date: March 2015