Clinical trials: sponsored by Luye Pharma Group Ltd.
Osteoporosis, Postmenopausal
Comparative Efficacy, Safety, PK, and Immunogenicity Study
this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women…
- Trial name
- NCT05853354
- Testing
- Denosumab
- Where
- 39 sites in United States, Bulgaria and 3 more
- Volunteers
- 392 people
- Sponsor
- Luye Pharma Group Ltd.
Advanced Solid Tumors
Safety, Tolerability, Pharmacokinetics (PK), and Primary Clinical Efficacy of LY01616 in Patients With Advanced Solid Tumors
This is a multicenter, open, dose escalation, single and multiple administration phase Ⅰ/Ⅱ clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), and primary clinical efficacy of LY01616 in patients with…
- Trial name
- NCT05865925
- Testing
- LY010616
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Luye Pharma Group Ltd.
Small Cell Lung Cancer
Irinotecan Hydrochloride Liposome Injection (LY01610) For Small Cell Lung Cancer
This is a Multicenter, Non-randomized, Open Label, Multiple Dose, Multiple administration, Phase IIa Clinical Study Evaluating the Efficacy and Safety of LY01610 in Patients with Extensive-stage Small Cell Lung Cancer that…
- Trial name
- NCT04381910
- Testing
- LY01610( Irinotecan hydrochloride liposome injection )
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Luye Pharma Group Ltd.
Schizophrenia, Psychotic Disorders
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration.
- Conditions
- Schizophrenia, Psychotic Disorders, Mood Disorders, Schizophrenia Spectrum and Other Psychotic Disorders
- Trial name
- NCT05321602
- Testing
- LY03010 156 mg treatment group, deltoid, LY03010 156 mg treatment group, gluteal, LY03010 351 mg treatment group, deltoid
- Where
- 9 sites in United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Relapsed Small Cell Lung Cancer
Study of LY01610 in Patients With Recurrent Small Cell Lung Cancer
This is a multicenter，randomized, open label, active-controlled, parallel-group study comparing efficacy and safety of LY01610(Irinotecan hydrochloride liposome Injection) and Topotecan in Patients with Recurrent Small Cell Lung…
- Trial name
- NCT06128837
- Testing
- Irinotecan hydrochloride liposome Injection, Topotecan
- Where
- China
- Volunteers
- 686 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Advanced Solid Tumor
First-in-Human Study of LPM6690176 in Patients With Advanced Solid Tumors.
This study is a phase 1, first-in-human, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and tolerability, pharmacokinetics characteristics and preliminary anti-tumor activity of LPM6690176…
- Trial name
- NCT06240546
- Testing
- LPM6690176
- Where
- China
- Volunteers
- 102 people
- Sponsor
- Luye Pharma Group Ltd.
Huntington Disease, Tardive Dyskinesia
A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects
This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164 sustained-release tablets orally administered in healthy…
- Trial name
- NCT05238701
- Testing
- LPM3770164 sustained release tablet, LPM3770164 sustained release tablet simulant
- Where
- China
- Volunteers
- 104 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 Abdominal 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
- NCT06204120
- Testing
- LPM3480392 Injection, morphine hydrochloride injection
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Luye Pharma Group Ltd.
Advanced Breast Cancer
Comparing the Pharmacokinetic Profile of LY01612 and CAELYX® in Chinese Subjects With Advanced Breast Cancer
A multicenter, randomized, open-lable, single-dose, two-cycle, double-cross bioequivalence study comparing the pharmacokinetic profile of LY01612 (Doxorubicin hydrochloride liposome injection) and CAELYX® in Chinese subjects with…
- Trial name
- NCT06098599
- Testing
- Doxorubicin hydrochloride liposome injection
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Luye Pharma Group Ltd.
Healthy
Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (13.3mg/24h)
The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 13.3 mg/24 h (Luye Pharma AG, Germany) and the marketed…
- Trial name
- NCT05853341
- Testing
- RID-TDS 13.3 mg/24 h, Exelon® 13.3 mg/24 h
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy
A Dose-escalation Study of LPM3480392 in Chinese Healthy Subjects
This is a randomized, double-blind, placebo-controlled, dose-increasing Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous infusion of LPM3480392 injection…
- Trial name
- NCT05862974
- Testing
- LPM3480392
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PD
This study is to evaluate the pharmacokinetics and safety of LY03003 in patients with advanced-stage PD.
- Trial name
- NCT04630860
- Testing
- LY03003
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Luye Pharma Group Ltd.
Breast Cancer
Efficacy and Safety of LY01005 in Patients With Breast 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
- NCT05110170
- Testing
- LY01005, ZOLADEX® 3.6 mg
- Where
- China
- Volunteers
- 188 people
- Sponsor
- Luye Pharma Group Ltd.
Prostate Cancer
Pharmacokinetics, Pharmacodynamics and Safety of LY01005 in Patients With Prostate Cancer Compared to ZOLADEX®
This is a randomized, open-label and parallel phase I study to compare pharmacokinetics (PK), pharmacodynamics (PD) and safety of goserelin acetate sustained-release microspheres for injection (LY01005) and ZOLADEX® following…
- Trial name
- NCT05140512
- Testing
- LY01005, ZOLADEX® 3.6 mg
- Where
- China
- Volunteers
- 23 people
- Sponsor
- Luye Pharma Group Ltd.
Prostate Cancer
Pharmacokinetics Pharmacodynamics and Safety of LY01022 in Patients With Prostate Cancer Compared With Zoladex® 10.8mg
This is a randomized, open-label, Parallel, active-controlled phase I study. A total of 20-24 patients with locally advanced or metastatic prostate cancer will be randomized in a 1:1 ratio to receive a single injection of LY01022…
- Trial name
- NCT05856630
- Testing
- Goserelin Acetate Sustained-Release Microspheres for Injection, Zoladex 10.8 MG Drug Implant
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Luye Pharma Group Ltd.
Healthy
An Exploratory Study of LPM3480392 at Different Infusion Rates in Chinese Healthy Subjects
This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392 injection by intravenous infusion at different rates in healthy subjects.The experiment was divided into Part A and Part B.
- Trial name
- NCT05857449
- Testing
- LPM3480392
- Where
- China
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Parkinson Disease
A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD
This study is to evaluate the effictiveness and safety of Ly03003 following intramuscular injections
- Trial name
- NCT04571164
- Testing
- LY03003(Rotigotine,extended-release microspheres)
- Where
- China
- Volunteers
- 294 people
- Sponsor
- Luye Pharma Group Ltd.
Advanced Solid Tumor
Irinotecan Hydrochloride Liposome Injection (LY01610) For Advanced Solid Tumors
This is a Phase I, open-label, non-randomized, dose-escalation study to evaluate the safety and tolerability, the maximum tolerated dose (MTD) and the dose limited toxicity(DLT) of LY01610 monotherapy and combine with 5-Fu in…
- Trial name
- NCT04088604
- Testing
- LY01610 ( Irinotecan hydrochloride liposome injection ), LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection）, Irinotecan Hydrochloride Injection（CAMPTO®）
- Where
- China
- Volunteers
- 38 people
- Sponsor
- Luye Pharma Group Ltd.
Schizophrenia, Psychotic Disorders
Relative Bioavailability of LY03010 Compared to Listed Drug
This is a randomized, multiple-dose, open-label, parallel-group study. Subjects will undergo screening evaluations to determine eligibility within 28 days prior to study drug administration.
- Conditions
- Schizophrenia, Psychotic Disorders, Mood Disorders, Schizophrenia Spectrum
- Trial name
- NCT04922593
- Testing
- LY03010; paliperidone palmitate, INVEGA SUSTENNA
- Where
- 9 sites in United States
- Volunteers
- 281 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Major Depressive Disorder (MDD)
A Study to Evaluate the Efficacy and Safety of Ansofaxine Hydrochloride Extended-release Tablets in the Treatment of Major Depressive Disorder (MDD)
The purpose of this study is to determine if LY03005 is effective and safe in improve MADRS score, as compared to placebo (no medicine) in participants with Major Depressive Disorder (MDD)
- Trial name
- NCT04853407
- Testing
- LY03005 extended-release tablet
- Where
- China
- Volunteers
- 558 people
- Sponsor
- Luye Pharma Group Ltd.