Clinical trials: open to volunteers, sponsored by Sunshine Lake Pharma Co., Ltd.
Healthy Subjects
A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects
This trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose…
- Trial name
- NCT07102251
- Testing
- HEC-007 injection
- Where
- China
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- 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.
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.
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.
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.