Who is sponsoring NCT02271412?

NCT02271412 is sponsored by Luye Pharma Group Ltd..

What drugs are being tested in NCT02271412?

Interventions in NCT02271412: LY03005, Placebo.

What condition does NCT02271412 study?

NCT02271412 studies Major Depressive Disorder, Recurrent, Unspecified.

Is NCT02271412 still recruiting?

NCT02271412 is currently completed. Last updated 20 October 2015.

Last reviewed 2015-10-20 · How we verify

NCT02271412

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 20 October 2015

What this trial tests

Phase 1 trial testing LY03005 in Major Depressive Disorder, Recurrent, Unspecified in 58 participants. Completed in 1 March 2015.

Timeline

1 October 2014

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	Luye Pharma Group Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	basic science
Enrollment	58
Start date	1 October 2014
Primary completion	1 March 2015
Estimated completion	1 March 2015
Sites	1 location across United States

Drugs / interventions tested

LY03005
Placebo

Conditions studied

Major Depressive Disorder, Recurrent, Unspecified — all drugs for Major Depressive Disorder, Recurrent, Unspecified →

Sponsor

Luye Pharma Group Ltd. — full company profile →

Who can join

Adults 18 to 45, any sex, with Major Depressive Disorder, Recurrent, Unspecified. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Adverse Events
Time frame: 3 to 4 months
Safety and Tolerability of LY03005

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy, Tolerability, and Safety of Toludesvenlafaxine for the Treatment of Major Depressive Disorder-A Narrative Review.
Vasiliu O. · · 2023 · cited 12× · PMID 36986510 · DOI 10.3390/ph16030411

Verify or expand the search:

Other trials of LY03005

Trials testing the same drug.

NCT03822065 — A Relative Bioavailability Food Effect Study of LY03005 · Phase 1 · completed
NCT03733574 — A Study of LY03005 vs Pristiq · Phase 1 · completed
NCT03357796 — Relative Bioavailability (RBA) Study of LY03005 vs Pristiq® · Phase 1 · completed
NCT02988024 — Pilot BA Study of New LY03005 vs Pristiq · Phase 1 · completed

Other Luye Pharma Group Ltd. trials

Trials by the same sponsor.

NCT07516899 — Mass Balance Study of [14C] LPM3770164 in Healthy Participants · Phase 1 · not yet recruiting
NCT07391566 — LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation · Phase 1, PHASE2 · not yet recruiting
NCT07396870 — A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia · Phase 2 · not yet recruiting
NCT07371065 — To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Sub · Phase 1 · enrolling by invitation
NCT07230652 — A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020 · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02271412 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Luye Pharma Group Ltd.
Last refreshed: 20 October 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02271412.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing