Clinical trials: sponsored by Luye Pharma Group Ltd.
Healthy Participants
A Study of LY03015 in Healthy Chinese and Caucasian Adult Subjects
This is an open-label, single-dose, parallel-group study to evaluate the safety, tolerability and pharmacokinetic characteristics of LY03015 in healthy Chinese and Caucasian adult subjects.
- Trial name
- NCT07671833
- Testing
- LY03015 (LPM3770164 extended-release tablets)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Generalized Anxiety Disorder
A Study to Evaluate Efficacy and Safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets in Generalized Anxiety Disorder.
The study aims to evaluate the efficacy and safety of Toludesvenlafaxine Hydrochloride Sustained-release Tablets compared to placebo in adults participants with generalized anxiety disorder over a period of 8 weeks.
- Trial name
- NCT05970510
- Testing
- Toludesvenlafaxine Hydrochloride Sustained-release Tablet 80mg, Toludesvenlafaxine Hydrochloride Sustained-release Tablet 160mg
- Where
- China
- Volunteers
- 555 people
- Sponsor
- Luye Pharma Group Ltd.
Huntington Disease
Mass Balance Study of [14C] LPM3770164 in Healthy Participants
This is a phase 1, single-center, single-dose, open-label mass-balance study to evaluate radioactive recovery rate, radioactive PK characteristics, metabolite identification, and to observe the safety in healthy male subjects of…
- Trial name
- NCT07516899
- Testing
- [14C] LPM3770164
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Schizophrenia
A Phase 2 Study to Evaluate the Efficacy and Safety of LY03020 in Acutely Psychotic Participants With Schizophrenia
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, fixed-dosed phase II clinical study to evaluate the efficacy and safety of LY03020 in chinese acutely psychotic adult subjects with…
- Trial name
- NCT07396870
- Testing
- LY03020
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Luye Pharma Group Ltd.
Metastatic Colorectal Cancer (mCRC)
LPM6690176 in Combination With Chemotherapy and Bevacizumab in Metastatic Colorectal Cancer Patients With RAS Mutation
This study is consist of phase 1b (dose escalation + safety run-in) and phase 2 (randomized, controlled). Phase 1b is planned to evaluate the safety and tolerability of LPM6690176 capsule in combination with chemotherapy and…
- Trial name
- NCT07391566
- Testing
- LPM6690176, Bevacizumab, FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
- Where
- China
- Volunteers
- 99 people
- Sponsor
- Luye Pharma Group Ltd.
Major Depressive Disorder
To Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Food Effects of LY03021 in Healthy Chinese Subjects
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…
- Trial name
- NCT07371065
- Testing
- LY03021
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Schizophrenia, Alzheimer's Disease Psychosis
A Food Effect Study of LY03020 in Healthy Subjects
This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.
- Trial name
- NCT07292233
- Testing
- LY03020
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Schizophrenia, Alzheimer's Disease Psychosis
A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and/or subjects with stable…
- Trial name
- NCT07230652
- Testing
- LY03020
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Assisted Reproduction
Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI).
- Trial name
- NCT07236476
- Testing
- LY01021
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Luye Pharma Group Ltd.
Schizophrenia, Alzheimer's Disease Psychosis
A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.
- Trial name
- NCT06556966
- Testing
- LY03020
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis
A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017
This is a phase 1，randomized, double-blind, placebo-controlled, MAD study to evaluate the safety, tolerability and pharmacokinetics of oral LPM526000133 Fumarate Capsules (LY03017) in healthy adult subjects
- Conditions
- Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis, Negative Symptoms of Schizophrenia
- Trial name
- NCT06980207
- Testing
- LY03017
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Alzheimer's Disease Psychosis, Parkinson Disease Psychosis
Effect of Food and Age on the Pharmacokinetics of LY03017
This study consists of 2 parts. Part A is a randomized, open-label, 2-period, crossover study to evaluate the food effect of LY03017 in healthy adults.
- Conditions
- Alzheimer's Disease Psychosis, Parkinson Disease Psychosis, Negative Symptoms of Schizophrenia
- Trial name
- NCT06793995
- Testing
- LY03017
- Where
- China
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Tardive Dyskinesia (TD)
Safety and Efficacy of LPM3770164 Sustained-release Tablets in Patients With Tardive Dyskinesia
This is a multicenter, randomized, double-blind, placebo-controlled parallel-group trial to evaluate the safety, tolerability, preliminary efficacy and PK characteristics of multiple doses of LPM3770164 sustained-release tablets…
- Trial name
- NCT06731868
- Testing
- LPM3770164 sustained release tablet 5 mg, LPM3770164 sustained release tablet 10 mg, LPM3770164 sustained release tablet 20 mg
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Luye Pharma Group Ltd.
Huntington Disease, Tardive Dyskinesia
Effect of Food on the Pharmacokinetics of LPM3770164 Sustained-release Tablets
This is a A single-center, randomized, open-label, two-dose, two-period, crossover trial was conducted to evaluate the effect of food on the Pharmacokinetic characteristics and safety of oral administration of LPM3770164…
- Trial name
- NCT06474650
- Testing
- LPM3770164 sustained release tablet
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Relapsed Small Cell Lung Cancer
Lurbinectedin or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed SCLC
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined…
- Trial name
- NCT06496048
- Testing
- Lurbinectedin, Irinotecan, Topotecan
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Luye Pharma Group Ltd.
Tardive Dyskinesia, Huntington Disease
Safety, Tolerability and Pharmacokinetic of Multiple-ascending Doses of LPM3770164 in Healthy Subjects
This is a single-center, randomized, double-blind, placebo-controlled, multiple-ascending doses trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy…
- Trial name
- NCT06216054
- Testing
- LPM3770164 sustained release tablet, LPM3770164 sustained release tablet simulant
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Pain, Postoperative
Phase II Clinical Trial to Evaluate the Efficacy and Safety of LPM3480392 Injection for Moderate to Severe Pain After Orthopedic Surgery
A randomized, double-blind, placebo/positive drug parallel controlled design was used to evaluate the preliminary efficacy and safety of intravenous infusion of LPM3480392 injection using different dosing regimens in subjects…
- Trial name
- NCT06467409
- Testing
- morphine hydrochloride injection, LPM3480392 Injection
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Luye Pharma Group Ltd.
Advanced Solid Tumor
Safety Tolerability Pharmacokinetic and Preliminary Efficacy in Chinese Advanced Solid Tumors Patients
Phase 1, single-arm, open-label, dose escalating and expansion clinical trial to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of Lurbinectedin (PM01183) for injection in patients with advanced solid…
- Trial name
- NCT04638491
- Testing
- Lurbinectedin for injection
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Luye Pharma Group Ltd.
Major Depressive Disorder
To Evaluate the Long-term Efficacy and Safety of Toludevenlafaxine Hydrochloride Sustained-release Tablets
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…
- Trial name
- NCT06426485
- Testing
- Toludesvenlafaxine Hydrochloride Sustained-release Tablets
- Volunteers
- 736 people
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
Clinical Trial to Investigate Patch Adhesion of Rotigotine Containing Patches in Patients With Parkinson's Disease
The investigational medicinal product (IMP) to be tested in the clinical trial (Rotigotine (ROT)-Transdermal System (TDS) (8 mg/24 h)), which is subject to this submission, was designed as a generic of Neupro® 8 mg/24 h, which is…
- Trial name
- NCT06247410
- Testing
- Rotigotine 8Mg/24Hrs Patch
- Where
- 8 sites in Germany
- Volunteers
- 38 people
- Sponsor
- SocraTec R&D GmbH