NCT02271412

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Luye Pharma Group Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Major Depressive Disorder, Recurrent, Unspecified

Interventions

Type	Name	Description
DRUG	LY03005	LY03005 is a new investigational pro-drug of desvenlafaxine formulated as extended-release oral tablets for the treatment of major depressive disorder.
DRUG	Placebo	Placebo

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-10-22
• Last updated: 2015-10-21

Locations

1 site across 1 country: United States