Clinical trials: sponsored by Shandong New Time Pharmaceutical Co., LTD
Efficacy and Safety
A Phase IV Study of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver
An open Label, Single-arm, Multicenter phase IV study; There was a 2-week screening period and a 12-week / 24-week treatment period
- Trial name
- NCT06202456
- Testing
- Huazhi Rougan granule
- Where
- China
- Volunteers
- 2,007 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
A Phase IV Trial to Investigate the Efficacy and Safety of Huazhi Rougan Granule in the Treatment of Non-alcoholic Simple Fatty Liver
A Phase IV Study of Huazhi Rougan Granule
A Placebo control, Randomized, Double-blind, Multicenter Phase IV study to investigate the efficacy and safety of Huazhi Rougan granule in the treatment of non-alcoholic simple fatty liver (damp-heat obstruction syndrome…
- Trial name
- NCT06188611
- Where
- China
- Volunteers
- 282 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Hepatocellular Carcinoma
the Efficacy and Safety of Rulonilimab in Combination With Lenvatinib in Hepatocellular Carcinoma
There are two studies included in this protocol. One is an open-label Phase Ⅱ study . The other is a multi-center, double-blind, randomized, phase III study .
- Trial name
- HCC (NCT05408221)
- Testing
- Rulonilimab+Lenvatinib
- Where
- 5 sites in China
- Volunteers
- 576 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Non-small Cell Lung Cancer, NSCLC
A Phase II Study of Rulonilimab Combined With Chemotherapy in the First-Line Treatment for Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
This is a single-arm, open-label, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of rulonilimab combined with chemotherapy in patients with advanced or metastatic non-small cell lung Cancer (NSCLC).
- Conditions
- Non-small Cell Lung Cancer, NSCLC, PD-1
- Trial name
- NCT05741021
- Testing
- F520, Pemetrexed, Carboplatin
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Solid Tumors
Efficacy and Safety Study of F520 Combined With Lenvatinib in the Treatment of Patients With Advanced Solid Tumors
This is a multicenter, open-label, phase Ib/II study on the efficacy and safety of F520 combined with lenvatinib in the treatment of patients with advanced solid tumors.
- Trial name
- NCT05740215
- Testing
- F520, Lenvatinib
- Where
- China
- Volunteers
- 158 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Osteoporosis
A Phase III Clinical Study of Minodronate Tablets in Postmenopausal Women With Osteoporosis
In the randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of monthly oral minodronate were examined and compared to that of weekly oral alendronate.
- Trial name
- NCT05305183
- Where
- China
- Volunteers
- 330 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Relapsed/Refractory Lymphoma
Study of F527 in Patients With Relapsed or Refractory Lymphoma
This study is a non-randomized, open-label, phase I dose-finding and dose-expansion study to evaluate the safety, tolerability, antitumor efficacy, PK and immunogen of F527 in patients with relapsed or refractory lymphoma sexual…
- Trial name
- NCT05293028
- Testing
- F527
- Where
- China
- Volunteers
- 82 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
RR DLBCL; PD-1; CD20
A Phase II Study to Evaluate the Efficacy and Safety of F520 Combined With F007 in Patients With RR DLBCL
This is an open-label, single-arm, and multicenter phase Ⅱ study designed to evaluate the efficacy and safety of F520 (PD-1) combined with F007(rituximab biosimilar) in patients with Relapsed/Refractory diffuse large B-cell…
- Trial name
- NCT05178836
- Testing
- F520+F007
- Volunteers
- 62 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Bioequivalence
Pharmacodynamic Equivalence Study Of Orlistat Capsules 60 mg
The study will start with a run-in period with controlled diet and no drug for 5 consecutive days. This is to accustom the subjects to the standardized diet and also to determine baseline fecal fat excretion.
- Trial name
- NCT05076474
- Testing
- Orlistat 60mg Cap
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Recruiting
A Study Comparing the Efficacy and Safety Between H-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients
This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase Ⅲ study. Primary objective: The purpose is to compare the objective response rate of H02 (rituximab biosimilar) plus CHOP and…
- Trial name
- NCT05040906
- Testing
- H02+CHOP, Rituxan +CHOP
- Where
- China
- Volunteers
- 416 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma
Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma
This trial is a Multiple center, Open-label, dose escalation Phase Ⅰ clinical study. The purpose is to evaluate the safety and tolerability of F182112 when infused intravenously (IV) and determine the maximum tolerated dose (MTD)…
- Trial name
- NCT04984434
- Testing
- F182112
- Where
- China
- Volunteers
- 68 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Locally Advanced or Metastatic Urothelial Cell Carcinoma
A Phase Ⅱ Study of F520 in Patients With Urothelial Carcinoma
This is a multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody F520 in participants with locally advanced or metastatic Urothelial Cancer (UC).
- Trial name
- NCT04636515
- Testing
- F520
- Volunteers
- 80 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Advanced Solid Tumor，Recurrent Solid Tumor，Lymphoma，Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma
Phase Ⅰ Study to Evaluate the Safety and Tolerability of Using F520
Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: F520) is joint developed by Shandong New Time Pharmaceutical Co., LTD., it is the reorganization of deoxyribonucleic acid (DNA)…
- Trial name
- NCT03657381
- Testing
- Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma
A Study of F520 in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL)
It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase II clinical study to evaluate the efficacy and safety of F520 for the treatment of Relapsed/Refractory Primary Central Nervous System…
- Trial name
- NCT04457869
- Testing
- F520
- Volunteers
- 43 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD
Peripheral T Cell Lymphoma
The Efficacy and Safety of F520 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).
It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase II clinical study to evaluate the efficacy and safety of F520 for the treatment of relapsed and refractory peripheral T cell lymphoma…
- Trial name
- NCT04457830
- Testing
- F520
- Volunteers
- 105 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD