Clinical trials: sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.
Locally Advanced Solid Tumors
A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors
This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced/Metastatic Solid Tumors
- Trial name
- NCT07050459
- Testing
- SIM0686
- Where
- 10 sites in China
- Volunteers
- 220 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Malignant Ascites
A Phase I Study of SIM0388 in Participants With Malignant Ascites.
Malignant Ascites is a common complication of malignant tumor. The objective of this study is to evaluate the safety, efficacy, and pharmacokinetic characteristics of intraperitoneal perfusion with Docetaxel Polymeric Micelles…
- Trial name
- SIM0388-101 (NCT07007988)
- Testing
- SIM0388
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with…
- Trial name
- NCT06186414
- Testing
- SIM0237, SIM0237 and BCG
- Where
- 14 sites in China
- Volunteers
- 152 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Solid Tumors
Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic…
- Trial name
- NCT06686745
- Testing
- SIM0508 Tablets, SIM0508 in combination with olaparib
- Where
- 2 sites in China
- Volunteers
- 130 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Locally Advanced Unresectable or Metastatic Solid Tumor
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0237 in Adult Participants with Advanced Solid Tumors
This is a multicenter, open-label, phase I study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic(PD) characteristics of SIM0237 in participants with advanced solid tumors.
- Trial name
- NCT05781360
- Testing
- SIM0237
- Where
- 9 sites in United States, China
- Volunteers
- 192 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Participants
Evaluate the Effects of Food on the Pharmacokinetics of SIM0270
This is a randomized, open label, single dose, two-period, crossover trial phase I study. The purpose of this study is to evaluate the food effect on the pharmacokinetics（PK） of SIM0270 after oral administration under fasted…
- Trial name
- NCT06536036
- Testing
- SIM0270
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Breast Cancer
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen…
- Trial name
- NCT05293964
- Testing
- SIM0270, Palbociclib, everolimus
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Participants
Mass Balance Clinical Trial of SIM0270
This is a single-center, non-randomized, open-label, single-cohort, single-dose phase I clinical study in healthy Chinese adult male subjects.
- Trial name
- NCT06654791
- Testing
- [14C] SIM0270 Oral Preparation
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Insomnia Disorder
A Study of Daridorexant in Chinese Patients With Insomnia Disorder
The primary purpose of this study is to assess the efficacy and safety of 50 mg daridorexant in adult and elderly chinese patients with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters .
- Trial name
- NCT06010693
- Testing
- Daridorexant
- Where
- 33 sites in China
- Volunteers
- 206 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Extensive-stage Small-cell Lung Cancer
Phase 3 Study Evaluating Efficacy, Safety and Pharmacokinetics of Trilaciclib In Small Cell Lung Cancer Patients
A Randomized, double-blind, placebo-controlled, multi-center Phase 3 study evaluating efficacy, safety and pharmacokinetics of Trilaciclib In Extensive-Stage Small Cell Lung Cancer Patients Receiving Carboplatin combined with…
- Trial name
- NCT04902885
- Testing
- Trilaciclib, carboplatin, etoposide，or Topotecan
- Where
- China
- Volunteers
- 95 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Volunteer
Investigate the PK, Safety, and Tolerability After Single and Multiple Dose Daridorexant in Chinese Healthy Subjects
This clinical study is a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical study to assess the PK characteristics and safety and tolerability of single and multiple dose daridorexant in 32 healthy adult…
- Trial name
- NCT06326723
- Testing
- Daridorexant
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Solid Tumor
A Phase II Study of Envofolimab and BD0801 With/Without Chemotherapy in Patients With Advanced Solid Tumors
This is an open label, multi-cohort, multicenter Phase II study, the purpose of this study is to assess the efficacy and safety of envofolimab in combination with BD0801 injection with/without chemotherapy for the treatment of…
- Trial name
- NCT05148195
- Testing
- Envofolimab, BD0801, Docetaxel
- Where
- 24 sites in China
- Volunteers
- 86 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Acute Ischemic Stroke, Cerebral Edema
The Tolerability, Safety, and PK Characteristics of SIM1910-09 in Healthy Chinese Volunteers
This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the tolerability, safety, and pharmacokinetic characteristics of SIM1910-09 for injection after single/multiple dosing in…
- Trial name
- NCT05200728
- Testing
- SIM1910-09
- Where
- China
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Extensive-stage Small-cell Lung Cancer
Evaluation of TRILACICLIB in Chinese Patients With Extensive-stage Small Cell Lung Cancer (ES-SCLC) for Chemotherapy-induced Myelosuppression, Antitumor Effects of Combination Regimens, and Safety in a Real-world Study
This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the…
- Trial name
- NCT05071703
- Testing
- Trilaciclib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
COVID-19 Patients
To Evaluate SSD8432/ Ritonavir in Adults With COVID-19
This is a randomized, double-blind, Phase 1b clinical trial to evaluate the safety, Pharmacodynamics, and Pharmacokinetic of SSD8432 combined with ritonavir tablets in adults with COVID-19.
- Trial name
- NCT05369676
- Testing
- SSD8432 dose 1/Ritonavir, SSD8432 dose 2/Ritonavir
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
COVID-19
A Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19
This Phase Ⅱ/Ⅲ study is to evaluate whether or not there is a difference in time recovery of COVID-19 signs and symptoms through Day 29 between SIM0417/ritonavir and placebo.
- Trial name
- NCT05506176
- Testing
- SIM0417
- Where
- 35 sites in China
- Volunteers
- 1,208 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Elder
Safety and Pharmacokinetics of SIM0417 Combined With Ritonavir in Healthy Elderly Subjects
This is a non-randomized, open-label, single-dose, Phase I clinical study and plans to enroll 12-20 healthy elderly subjects aged 65 and above, including 3-6 subjects aged 75 and above, both men and women.
- Trial name
- NCT05826249
- Testing
- SIM0417/Ritonavir
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Renal Impairment, Hepatic Impairment
Hepatic Impairment and Renal Impairment Study of SIM0417 Combined With Ritonavir
This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild…
- Trial name
- NCT05731804
- Testing
- SIM0417 600 mg; Ritonavir100 mg, SIM0417 375 mg; Ritonavir100 mg, SIM0417 750 mg; Ritonavir100 mg
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Volunteers
Drug-Drug Interaction Study of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Participants
This is a phase 1, open-label, fixed-sequence, 2-period drug-drug interaction study to evaluate the pharmacokinetic interactions of itraconazole, rifampicin, midazolam, and SIM0417/ritonavir in healthy Chinese subjects.
- Trial name
- NCT05665647
- Testing
- Cohort 1: SIM0417/ritonavir and itraconazole, Cohort 2: SIM0417/ritonavir and rifampicin, Cohort 3: SIM0417/ritonavir and midazolam
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Advanced Solid Tumor, Cutaneous T-cell Lymphoma (CTCL)
A Phase I Trial of SIM1811-03 in Subjects With Advanced Solid Tumors and Cutaneous T-cell Lymphoma
This is a first in human, open-label, dose escalation and expansion Phase 1 study of SIM1811-03 in adult patients with advanced solid tumors and cutaneous T-cell lymphoma.
- Trial name
- NCT05569057
- Testing
- SIM1811-03
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.