Clinical trials: sponsored by Sunshine Lake Pharma Co., Ltd.
Gout
A Clinical Trial of HEC93077 in Chinese Healthy Subjects and HUA Patients With Single or Multiple Dosing
A phase 1 clinical trial of HEC93077,to evaluate the safety ,PK,PD and food effect in Chinese healthy subjects and HUA patients after single or multiple dosing.
- Trial name
- NCT05127772
- Testing
- HEC93077
- Where
- China
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Type 2 Diabetes
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
- Trial name
- NCT05374343
- Testing
- pyroglutamate rongliflozin capsules
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Leukemia, Acute Myeloid (AML)
HEC73543 Versus Salvage Chemotherapy in R/R FLT3-ITD AML
A randomized，multicenter, open-label Phase III, clinical study is conducted to evaluate the clinical benefit Clifutinib in Chinese patients with relapsed/ refractory (R/R) FLT3-mutated AML as shown with overall survival compared…
- Trial name
- NCT05586074
- Testing
- Clifutinib, LoDAC, Azacitidine
- Where
- China
- Volunteers
- 324 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Adult Subject
A Single-center, Randomized, Open-label, Parallel-design Clinical Study to Evaluate the Pharmacokinetic Effects of Itraconazole, Fluconazole or Efavirenz on a Single Dose of Clifutinib in Healthy Participants
Evaluate the pharmacokinetic effects of itraconazole, fluconazole, or efavirenz on a single - dose of Clifutinib and the safety of the combination therapy in healthy participants.
- Trial name
- NCT07341672
- Testing
- Clifutinib, Itraconazole, fluconazole
- Where
- China
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Progressive Fibrosing Interstitial Lung Disease (PF-ILD) / Progressive Pulmonary Fibrosis (PPF)
A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients
The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing…
- Trial name
- NCT05139719
- Testing
- HEC585 dose A, HEC585 dose B
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Idiopathic Pulmonary Fibrosis (IPF)
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)
- Trial name
- NCT07082842
- Testing
- HEC585, Pirfenidone
- Where
- China
- Volunteers
- 472 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Idiopathic Pulmonary Fibrosis
Phase ll Study of HEC585 in Patients With IPF
A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
- Trial name
- NCT05060822
- Testing
- HEC585, Pirfenidone
- Where
- China
- Volunteers
- 270 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Adult Male
Clinical Study on the Mass Balance of Clifutinib
To investigate the plasma total radioactivity PK characteristics of male healthy subjects after a single oral administration of [14C]Clifutinib, the distribution of total radioactivity in whole blood and plasma, and to determine…
- Trial name
- NCT07211165
- Testing
- [14C]Clifutinib
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Volunteers
A Study to Evaluate Drug-Drug Interaction of Larotinib With Itraconazole and Rifampin in Healthy Adult Participants
The purpose of this study is to characterize the effect of rifampin (Part A) and itraconazole(Part B) on the single-dose pharmacokinetics (PK) of Larotinib in healthy adult participants.
- Trial name
- Z650 (NCT05057949)
- Testing
- Larotinib, Rifampin, Itraconazole
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Chronic Kidney Diseases, Renal Anemia
HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia
To evaluate the safety, tolerability , pharmacokinetics and Preliminary Efficacy of HEC53856 Capsules in Patients With Non-dialysis Renal Anemia.
- Trial name
- NCT04925661
- Testing
- HEC53856, Roxadustat
- Where
- 8 sites in China
- Volunteers
- 40 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hemodialysis, Peritoneal Dialysis
Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis.
To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of HEC53856 capsules on anemia in subjects with chronic kidney disease on dialysis.
- Trial name
- NCT04925674
- Testing
- HEC53856
- Where
- 7 sites in China
- Volunteers
- 60 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Chronic HCV Infection
Antaitavir Hasophate Capsules Combined With Yiqibuvir Tablets in Treatment Adult Patients With Chronic Hepatitis C
The safety, tolerability and antiviral activity of Antaitavir Hasophate in Combination With Yiqibuvir in treatment-naive and treatment-experienced patients with chronic hepatitis C virus (HCV) infection
- Trial name
- NCT05395416
- Testing
- HEC74647PA+HEC110114
- Where
- 36 sites in China
- Volunteers
- 514 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Acute Myeloid Leukemia
A Clinical Trial to Evaluate Clifutinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia(AML)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of Clifutinib Besylate in Relapsed/refractory AML patients with FLT3-ITD mutation.
- Trial name
- NCT04827069
- Testing
- Clifutinib Besylate
- Where
- China
- Volunteers
- 75 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Hepatitis B, Chronic
Evaluation HEC121120 Tolerance in Healthy Subjects and Patients With Chronic Hepatitis B, Pharmacokinetics Characteristics and Antiviral Activity of Ⅰ Phase of Study
The Safety, Tolerability, Pharmacokinetics and antiviral activity Study of Anti hepatitis B virus treatment drug HEC121120 in Healthy subjects and in patients with chronic hepatitis B
- Trial name
- NCT04536532
- Testing
- HEC121120 tablets, entecavir tablets
- Where
- China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Chronic HBV Infection
Evaluate the Safety, Tolerability, and Antiviral Activity of GLS4 With Ritonavir in Patients With Chronic HBV Infection
The experiment is divided into two parts: Part 1 and Part 2.Part 1 was the initial treatment patient and Part 2 was the treated patient.
- Trial name
- NCT04147208
- Testing
- GLS4, RTV, ETV
- Where
- 37 sites in China
- Volunteers
- 250 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Male Subjects
ADME Study of [14C] Yiqibuvir in Healthy Male Subjects
This is a single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] Yiqibuvir.
- Trial name
- NCT05998304
- Testing
- [14C] Yiqibuvir
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Non-Alcoholic Steatohepatitis
A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.
- Trial name
- NCT05397379
- Testing
- HEC96719
- Where
- 9 sites in China
- Volunteers
- 68 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Parkinson Disease
Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult Subjects
The Safety, Tolerability, Pharmacokinetic and Food Effect Study of HEC122505MsOH Tablets in Healthy Subjects
- Trial name
- NCT04625361
- Testing
- HEC122505MsOH
- Where
- China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy
HEC53856 Phase 1 Study - Single and Multiple Oral Dosing in Healthy Volunteers
To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.
- Trial name
- NCT03886688
- Testing
- HEC53856
- Where
- China
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Volunteer
Study on the Body Mass Balance and Biotransformation of [14C]-HEC585
This is a single-centre, open-label, non-randomised, single-dose study in healthy male subjects designed to assess the mass balance and biotransformation of [14C]-HEC-585.
- Trial name
- NCT05468346
- Testing
- [14C]-HEC585
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.