Clinical trials: sponsored by Luye Pharma Group Ltd.
Postmenopausal Osteoporosis
A Study to Evaluate the Efficacy and Safety of LY06006 in Postmenopausal Women With Osteoporosis at High Risk for Fracture
A multicenter, randomized, double-blind, placebo-controlled phase III clinical study will be conducted to evaluate the efficacy and safety of LY06006 in the treatment of postmenopausal women with osteoporosis at high risk for…
- Trial name
- NCT05060406
- Testing
- LY06006
- Where
- China
- Volunteers
- 448 people
- Sponsor
- Luye Pharma Group Ltd.
Prostate Cancer
Efficacy and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®
This is a multicenter, randomized, open-label, active comparator-controlled phase Ⅲ trial to compare efficacy and safety of Goserelin Acetate Sustained-Release Microspheres for Injection (LY01005) and ZOLADEX® in patients with…
- Trial name
- NCT04563936
- Testing
- LY01005 3.6 mg, ZOLADEX® 3.6 mg
- Where
- China
- Volunteers
- 290 people
- Sponsor
- Luye Pharma Group Ltd.
Healthy Adults
A Study to Evaluate LY06006 and Prolia in Healthy Adults
A randomized, double-blind, parallel-group study in Chinese healthy male subjects to evaluate the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY06006 versus Prolia following single-dose subcutaneous injection
- Trial name
- NCT04973722
- Testing
- LY06006, Prolia
- Where
- China
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Covid19
A Phase I Study of LY-CovMab Injection in Chinese Healthy Subjects
A single center, randomized, doubled-blind, placebo-control and single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of LY-CovMab Injection in Chinese healthy subjects.
- Trial name
- NCT04973735
- Testing
- LY-CovMab
- Where
- China
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Parkinson's Disease
to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers
The purpose of this study is to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy Volunteers.
- Trial name
- NCT04593511
- Testing
- LY03009 F1, LY03009 F2, LY03009 F3
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Bone Metastases From Solid Tumors
Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors
This is a multicenter，randomized, double-blind, active-controlled, parallel-group study comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody injection) and Xgeva® in patients with bone…
- Trial name
- NCT04859569
- Testing
- LY01011, Xgeva®
- Where
- China
- Volunteers
- 850 people
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
A Study to Assess Pharmacokinetic Profiles of LY03003 and Neupro
Phase 1, single center study to assess pharmacokinetic profiles of rotigotine after single dose of LY03003 and daily patch application of Neupro in Healthy Volunteers
- Trial name
- NCT03733561
- Testing
- LY03003, Neupro 4Mg/24Hr Transdermal Patch
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients
A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD Patients
- Trial name
- NCT04629404
- Testing
- LY03003
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003
This study is to evaluate the human tolerance and pharmacokinetics of LY03003.
- Trial name
- NCT04627155
- Testing
- LY03003
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Schizophrenia Patients
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
The primary objectives of the study are to characterize the pharmacokinetic (PK) profiles of paliperidone in LY03010 P1 and P2 following a single IM injection in schizophrenia patients and to compare the PK of LY03010 P1 and P2…
- Trial name
- NCT04572685
- Testing
- Paliperidone Palmitate
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy Volunteers
This is a randomized, open-label, 2-sequence, 2-treatment cross-over study in healthy adult subjects. Rotigotine PK profiles will be obtained from all subjects after both a single dose of 28 mg LY03003 and 1 week of 4 mg q24h…
- Trial name
- NCT04384666
- Testing
- LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection), Neupro 4 mg / 24 Hr. Transdermal Patch
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Age Related Macular Degeneration
A Study to Compare LY09004 and Eylea in the Treatment of Wet Age-related Macular Degeneration（wAMD）
A randomized, double-blind, parallel controlled, multicenter clinical trial to compare the efficacy and safety of LY09004 and EYLEA in the Treatment of Wet Age-related Macular Degeneration（wAMD)
- Trial name
- NCT04572698
- Testing
- LY09004, Eylea
- Volunteers
- 416 people
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease
This study is to evaluate the safety and tolerability and to characterize the pharmacokinetics of multiple ascending dose (MAD) of LY03003 following intramuscular injections.
- Trial name
- NCT04045678
- Testing
- LY03003 ( Rotigotine, extended-release microspheres)
- Where
- 3 sites in China
- Volunteers
- 30 people
- Sponsor
- Luye Pharma Group Ltd.
Healthy Adults
A Study to Evaluate LY01011 and Xgeva® in Healthy Adults
A randomized, double-blind, single-dose, parallel-group study to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of LY01011 and Xgeva® in healthy adults
- Trial name
- NCT04198636
- Testing
- LY01011, Xgeva 120 MG in 1.7 ML Injection
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Schizo Affective Disorder, Schizophrenia
A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients
This study will look at the Characteristics of LY03010 Versus INVEGA SUSTENNA® in the blood of Schizophrenia Patients
- Conditions
- Schizo Affective Disorder, Schizophrenia, Schizoaffective Disorder
- Trial name
- NCT03751488
- Testing
- LY03010, Invega Sustenna 156 MG in 1 ML Prefilled Syringe
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- Luye Pharma Group Ltd.
Major Depressive Disorder
A Relative Bioavailability Food Effect Study of LY03005
The objective if this study is to assess the relative bio-availability of single oral doses of 80 mg LY03005 tablets administered to healthy subjects under fed versus fasted conditions in a 2-period, crossover trial.
- Trial name
- NCT03822065
- Testing
- LY03005
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
A Study of LY03003 in Patients With Early-stage Parkinson's Disease
This study is to characterize the pharmacokinetics and to evaluate the safety as well as tolerability of LY03003 following multiple escalating intramuscular injections
- Trial name
- NCT04044547
- Testing
- Rotigotine, extended-release microspheres
- Volunteers
- 60 people
- Sponsor
- Luye Pharma Group Ltd.
Solid Tumor
A Study Evaluating the Safety, Tolerability of LPM3480226 Tablets in Patients With Advanced Solid Tumors
This study is a non-randomized, open, multiple administration and dose escalation phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetic/pharmacodynamics Characteristics of multiple oral administration of…
- Trial name
- NCT03844438
- Testing
- LPM3480226
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Luye Pharma Group Ltd.
Cancer of Prostate
A Study to Assess LY01005 Versus Goserelin Comparator (ZOLADEX®) in Patients With Prostate Cancer
A phase I, randomized, open-label and active-control study to assess the PK, PD and safety profiles of LY01005 versus goserelin comparator to be conducted in the USA.
- Trial name
- NCT03450109
- Testing
- LY01005, Zoladex
- Where
- 5 sites in United States
- Volunteers
- 19 people
- Sponsor
- Luye Pharma Group Ltd.
Major Depressive Disorder
Dose-Finding Clinical Trial to Evaluate the Efficacy and Safety of LY03005 Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
This study was a multicenter, randomized, double-blind, placebo, parallel-controlled, dose-finding Phase II clinical trial to find the optimal dose of LY03005 Extended-release Tablets for the treatment of MDD and to evaluate the…
- Trial name
- NCT03785652
- Testing
- LY03005 extended-release tablets 40 mg, LY03005 extended-release tablets 80 mg group, LY03005 extended-release tablets 120 mg group
- Where
- China
- Volunteers
- 260 people
- Sponsor
- Luye Pharma Group Ltd.