Clinical trials: sponsored by Sunshine Lake Pharma Co., Ltd.
Chemotherapy-induced Anemia, Non-Myeloid Malignancy
HEC53856 Tablets for Chemotherapy-induced Anemia in Non-myeloid Malignancies
A Phase II clinical trial to evaluate the efficacy and safety of different dosing regimens of HEC53856 tablets compared to rHuEPO injection in participants of the CIA trial.
- Trial name
- NCT07891377
- Testing
- HEC53856 tablet, rHuEPO injection
- Where
- China
- Volunteers
- 160 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Advanced Solid Tumor
HEC169096 in Participants With Advanced Solid Tumors
An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced…
- Trial name
- NCT05451602
- Testing
- HEC169096
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Esophageal Cancer
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
This is a randomized, controlled, multi-center, open trial, unresectable locally advanced or metastatic esophageal squamous cell carcinoma patients that failed at least second-line treatment and overexpressed EGFR were enrolled…
- Trial name
- NCT04415853
- Testing
- Lerotinib, Irinotecan/Tegafur
- Where
- China
- Volunteers
- 416 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Esophageal Cancer, Advanced Solid Tumor
Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function
To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
- Trial name
- NCT05048368
- Testing
- Larotinib
- Where
- China
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy Adult Male
Single-ascending Dose Study of HEC-151 Injection
Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants
- Trial name
- NCT07376200
- Testing
- HEC-151 Injection, Degludec insulin
- Where
- 2 sites in China
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Advanced Malignant Solid Tumors
HEC-921 Injection as Monotherapy and in Combination With Antineoplastic Therapies in Patients With Advanced Malignant Solid Tumors
A Phase I Study of HEC-921 Injection as Monotherapy and in Combination with Other AntineoplasticTherapy in Patients with Advanced Malignant Solid Tumors
- Trial name
- NCT07824934
- Testing
- HEC-921, Oxaliplatin, Capecitabine
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Non - Alcoholic Steatohepatitis
A Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Study of HEC169584 Capsules in Healthy Subjects
The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects .
- Trial name
- NCT07099118
- Testing
- HEC169584 capsule
- Where
- China
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Depressive Disorder, Major
The Efficacy And Safety Of Mitizodone Phosphate Tablets In The Treatment of Patient With Major Depressive Disorder
This is a phase 2 and 3 adaptive design study for Mitizodone Phosphate,to find out an optimal dose in phase 2 period and confirm the result an efficacy and safety in phase 3 period.Dose-finding will be done after 8 weeks of…
- Trial name
- NCT04984512
- Testing
- Mitizodone Phosphate tablets
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
HBV Infection
A Phase I Clinical Trial to Evaluate HECN30227 Injection in Healthy Subjects and Subjects With Chronic Hepatitis B
To evaluate the safety, efficacy, pharmacokinetics and immunogenicity of single and multiple doses of HECN30227 Injection in healthy volunteers and patients with chronic hepatitis B
- Trial name
- NCT07771140
- Testing
- HECN30227 injection(SAD), HECN30227 injection (MAD)
- Where
- China
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Acute Myeloid Leukemia, Adult
A Phase Ⅰb/Ⅱ Clinical Study of Clifutinib Besylate Combined With Chemotherapy in the Treatment of Newly Diagnosed AML
This is a multi-center open clinical study aimed at evaluating the efficacy and safety of Clifutinib Besylate combined with chemotherapy in newly-treated adult subjects with AML
- Trial name
- NCT05133882
- Testing
- Clifutinib Besylate
- Where
- China
- Volunteers
- 133 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Idiopathic Pulmonary Fibrosis
Study To Investigate The Potential DDI Between HEC585 And Pirfenidone/Nintedanib In Healthy Subjects
A single-center, open-label study designed to assess the drug-drug interaction of HEC585 and pirfenidone in healthy male and female subjects.
- Trial name
- NCT07588646
- Testing
- HEC585, Nintedanib, Pirfenidone
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Advanced NSCLC
Ningetinib in Advanced NSCLC Skipping Mutations With MET Exon 14 Skipping Mutations
This is a phase II, Single-arm,Open-label Study evaluating the safety and efficacy of CT053PTSA in Advanced Solid Tumors With MET Exon 14 Skipping Mutations
- Trial name
- NCT04992858
- Testing
- CT053PTSA
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Relapsed or Refractory B-cell Hematologic Malignancies
A Study to Evaluate the Tolerability, Safety, Pharmacokinetics of HEC89736 in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Evaluate the safety, pharmacokinetics and efficacy of HEC89736 in patients with Relapsed or Refractory B-cell Hematologic Malignancies
- Trial name
- NCT04865458
- Testing
- HEC89736
- Where
- 2 sites in China
- Volunteers
- 5 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Non-small Cell Lung Cancer
Ningetinib (CT053PTSA) Plus Gefitinib in Stage IIIB or IV NSCLC Patients With EGFR Mutation and T790M Negative
This is a phase Ib, multi-center, open label study evaluating the safety and efficacy of CT053PTSA in combination with gefitinib in patients with EGFR mutation, T790M negative NSCLC who have progressed after EGFR TKI treatment.
- Trial name
- NCT03758287
- Testing
- CT053PTSA, Gefitinib
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Diabetes Mellitus, Type 2
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Pyroglutamate Rongliflozin Capsules in Subjects With Mild and Moderate Liver Damage
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in subjects with mild and moderate liver damage and healthy subjects
- Trial name
- NCT05427682
- Testing
- pyroglutamate rongliflozin capsules
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Diabetes
A Study of Insulin Degludec/Insulin Aspart Biosimilar (22011) Compared With Insulin Degludec/Insulin Aspart(Ryzodeg) in Participants With Type 2 Diabetes in China
The purpose of this study is to see if Insulin Degludec/Insulin Aspart (22011) compared to Insulin Degludec/Insulin Aspart (Ryzodeg) is similar in safety and effect in participants with type 2 diabetes (T2D).
- Trial name
- NCT05802862
- Testing
- Insulin Degludec and Insulin Aspart
- Where
- China
- Volunteers
- 414 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Healthy
The Study of a Selective 5-ht6 Receptor Antagonist, HEC30654AcOH,in Healthy Subjects
This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of a selective 5-ht6 receptor antagonist, HEC30654AcOH,in healthy subjects.This test is divided into two parts, the first part is the healthy adult subjects…
- Trial name
- NCT03655873
- Testing
- HEC30654AcOH capsule
- Where
- China
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Insomnia
the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets
Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects
- Trial name
- NCT04667429
- Testing
- Food, HEC83518
- Where
- China
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- 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.
Insomnia
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects
The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets in Chinses Healthy Subjects
- Trial name
- NCT04596007
- Testing
- HEC83518 tablets
- Where
- China
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.