Clinical trials: sponsored by Luye Pharma Group Ltd.
Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis
A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017
This is a phase 1，randomized, double-blind, placebo-controlled, SAD 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
- NCT06388551
- Testing
- LY03017
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.