A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03005 (LY03005SAD)

NCT02055300 Phase 1 COMPLETED

The purpose of this study is to evaluate the safety and tolerability of escalating single oral doses of LY03005 in healthy subjects and to characterize the pharmacokinetics (PK) of escalating single oral doses of LY03005.

Details

Lead sponsor	Luye Pharma Group Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	88
Start date	2014-02
Completion	2014-08

Conditions

• Major Depressive Disorder

Interventions

• LY03005
• Placebo
• Meal
• Pristiq

Primary outcomes

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability — 11 Days

Countries

United States