Clinical trials: sponsored by Chengdu Zenitar Biomedical Technology Co., Ltd
- Lead sponsor (exact) Chengdu Zenitar Biomedical Technology Co., Ltd
- Funder type Industry (pharma, biotech, devices)
Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera
Flonoltinib Maleate Oral Regimens in Patients With Myelofibrosis
The goal of this clinical trial is to learn which of three different doses of Flonoltinib Maleate taken by mouth daily works best to treat adult patients with myelofibrosis in whom the most common approved therapy has failed to…
- Conditions
- Myelofibrosis, Myelofibrosis Due to and Following Polycythemia Vera, Myelofibrosis Transformation in Essential Thrombocythemia, Myelofibrosis With High Molecular Risk Mutations
- Trial name
- FM-MF-02 (NCT07750574)
- Testing
- Flonoltinib Maleate orally
- Volunteers
- 105 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
MB
Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants
This trial adopts a single-center, open-label, non-randomized, single-dose study design. It is planned to enroll 6 healthy Chinese male participants, and the final standard is to collect complete samples and data to be tested…
- Trial name
- NCT07809217
- Testing
- 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Drug Interaction Research
Clinical Study on Drug Interactions of Flonoltinib Maleate Tablets
This study is a single center, open label, fixed sequence drug interaction study to evaluate the effects of CYP3A4 inhibitor itraconazole and CYP3A4 inducer rifampicin on the pharmacokinetic characteristics of a single oral dose…
- Trial name
- NCT07768111
- Testing
- 75mg Flonoltinib, 100mg Flonoltinib
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Polycythemia Vera (PV)
Phase IIa Study of Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera
This trial adopts an open, randomized, parallel controlled, multicenter clinical trial design planning to enroll patients with polycythemia vera who are resistant/intolerant to hydroxyurea or interferon.
- Trial name
- NCT07232290
- Testing
- Flonoltinib 75mg, Flonoltinib 100mg, Flonoltinib 125mg
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
COVID-19
Study of Flonoltinib Maleate Tablets in the Treatment of Severe Novel Coronavirus (COVID-19) Infection
Flonoltinib Maleate (FM) is a triple-target inhibitor of JAK2, FLT3, and CDK6. It inhibited JAK2 with an IC50 of 0.8 nM, whereas its IC50 values against JAK1, JAK3, and TYK2 were 690 nM, 557 nM, and 65 nM, respectively…
- Trial name
- NCT05713279
- Testing
- SOC
- Where
- China
- Volunteers
- 13 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
MF
A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis
This trial adopts a multicenter, open label, positive drug parallel controlled clinical trial design, with a planned enrollment of approximately 105 participants in the MF trial.
- Trial name
- NCT07317700
- Testing
- Flonoltinib 75mg, Ruxolitinib Phosphate
- Where
- 2 sites in China
- Volunteers
- 105 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
MB
Mass Balance Study of [14C] Flonoltinib Maleate
The primary objectives are: 1. To investigate the total radioactivity in urine and feces after a single oral administration of [14C]Flonoltinib in healthy adult male participants, thereby obtaining human radioactive recovery…
- Trial name
- NCT07612306
- Testing
- Flonoltinib 75mg
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
MF
A Clinical Trial of Flonoltinib Maleate Tablets in the Treatment of JAK Inhibitor Refractory/Relapsed/Intolerant Patients With Intermediate to High Risk Myelofibrosis
This trial adopts a single arm, open label, multi center clinical trial design, with a planned enrollment of approximately 64 participants in the intermediate to high risk MF trial who are refractory, relapsed, or intolerant to…
- Trial name
- NCT07443306
- Testing
- Flonoltinib Maleate
- Where
- 2 sites in China
- Volunteers
- 64 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
MF,PMF,PPV-MF,PET-MF
A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis
This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants.
- Trial name
- NCT06457425
- Testing
- Flonoltinib 50mg, Flonoltinib 100mg, Ruxolitinib
- Where
- 2 sites in China
- Volunteers
- 75 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Healthy Participants Study
Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China
To evaluate the tolerability and safety of a single oral dose of ZL-65 tablets in healthy adult trial participants through dose escalation; and to preliminarily assess the pharmacokinetic and pharmacodynamic characteristics of a…
- Trial name
- NCT07757152
- Testing
- This group of participants take ZL-65 tablet
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL), Cutaneous T-cell Lymphoma (CTCL)
A Phase IIa Clinical Study of Purinostat Mesylate for Injection in Patients With Peripheral T-Cell Lymphoma and Cutaneous T-Cell Lymphoma
Primary Objective To evaluate the preliminary efficacy of Purinostat Mesylate for Injection in patients with relapsed or refractory Peripheral T-Cell Lymphoma (PTCL) and Cutaneous T-Cell Lymphoma (CTCL). Secondary Objectives 1.
- Trial name
- NCT06485219
- Testing
- 11.2 mg/m2 Purinostat Mesylate, 15 mg/m2 Purinostat Mesylate
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Atopic Dermatitis
A Phase II Clinical Study Evaluating of ZL-82 Tablets in Atopic Dermatitis
This clinical trial aims to explore whether the drug ZL-82 tablets can be used to treat moderate to severe atopic dermatitis in adults, and to understand the safety and tolerability of the drug.
- Trial name
- NCT07193589
- Testing
- The high-dose group of ZL-82 tablets, The low-dose group of ZL-82 tablets
- Where
- China
- Volunteers
- 111 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Diffuse Large B Cell Lymphoma，DLBCL
Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)
Purinostat mesylate for injection (PM) was the novel and highly potent Class Ia and IIb HDAC selective inhibitor. The results of regular blood sampling analysis of the mouse B-cell lymphoma model induced by ighmyc transgenic mice…
- Trial name
- NCT05563844
- Testing
- PM 8.4 mg/m^2, PM 11.2 mg/m^2
- Where
- 2 sites in China
- Volunteers
- 74 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Advanced Solid Tumor
A Clinical Study of ZL-85FA Tablets
An open-label, multicenter phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZL-85FA tablets in treating advanced solid tumors
- Trial name
- NCT07339748
- Testing
- ZL-85FA tablets
- Where
- China
- Volunteers
- 51 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Diffuse Large B Cell Lymphoma，DLBCL
Study of Purinostat Mesylate for Injection in the Treatment of Relapsed or Refractory B Cell-related Tumor-predominant
Purinostat mesylate for injection (PM) was the novel and highly potent Class I a and IIb HDAC-selective inhibitors. The results of regular blood sampling analysis of the mouse B-cell lymphoma model induced by ighmyc transgenic…
- Trial name
- NCT05526313
- Testing
- Purinostat Mesylate 1.2mg/m^2, Purinostat Mesylate 2.4mg/m^2, Purinostat Mesylate 4.0mg/m^2
- Where
- China
- Volunteers
- 29 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Myeloproliferative Neoplasm (MPN), Myelofibrosis，MF
Safety of Flonoltinib Maleate Tablets for the Treatment of Patients With Myeloproliferative
Flonoltinib Maleate (FM) targets Janus kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). FM is a dual target inhibitor of JAK2/FLT3.FM has the activity of inhibiting JAK2 signaling pathway, and pharmacodynamics evaluation…
- Trial name
- NCT05153343
- Testing
- flonoltinib 25mg, flonoltinib 100mg, flonoltinib 150mg
- Where
- China
- Volunteers
- 31 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Healthy Person
ZL-82 Double-blind Clinical Trial
ZL-82 tablets are highly selective covalent irreversible inhibitors of non-receptor tyrosine protein kinase 3 (Janus kinase 3, JAK3) developed by Chengdu Zenitar Biomedical Technology Co., Ltd. According to Document No.
- Trial name
- NCT06432738
- Testing
- ZL-82
- Where
- China
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Heathly Subjects
A Pharmacokinetic Study of the Food Effect on Flonoltinib Maleate Tablets
A Randomized, Open-Label, Two-Period, Two-Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of Flonoltinib Maleate Tablets in Healthy Subjects Under Fed Conditions
- Trial name
- NCT07193576
- Testing
- flunotinib
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Heathly Subjects
A Phase I Clinical Study of Flonoltinib Maleate Tablets in Healthy Subjects
Evaluate the safety , tolerability and pharmacokinetics of Flonoltinib Maleate tablets in a single increasing dose oral administered to healthy adult Chinese subjects.Subjects will divide into experimental group and placebo…
- Trial name
- NCT06387966
- Testing
- Flonoltinib Maleate Tablets
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Recurrent and Refractory Diffuse Large B-cell Lymphoma
A Phase III Clinical Study of Purinostat Mesylate for Injection in Patients With Diffuse Large B-cell Lymphoma
The main objective of this study is to evaluate the differences in objective response rate and overall survival between the Purinostat mesylate for injection and selinexor, as assessed by blinded independent central review…
- Trial name
- NCT07011056
- Testing
- Purinostat Mesylate for Injection, Selinexor Tablets
- Where
- China
- Volunteers
- 390 people
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd