Clinical trials: sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.
Health, Subjective
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of SIM0811 Injection in Healthy Chinese Adult Participants
This study plans to set up 5 dose groups across 7 cohorts, including intravenous bolus plus infusion administration as well as intravenous bolus alone.
- Trial name
- NCT07345364
- Testing
- SIM0811
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Adult Participants
An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants
This study is an open-label, fixed-sequence, two-period Phase 1 clinical trial in healthy adult Chinese participants with a total of 3 cohorts, 16-20 healthy adult Chinese participants are planned to be enrolled in each cohort.
- Trial name
- SIM0270-104 (NCT07357610)
- Testing
- SIM0270, itraconazole, Rifampin
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Volunteers
To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SIM0278 in Chinese Healthy Subjects
This is a Phase 1, randomized, double-blind, placebo-controlled trial of SIM0278 in healthy subjects. The study will be conducted in 2 parts. Part 1 is single ascending dose study. Part 2 is multiple ascending dose study.
- Trial name
- NCT06022354
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- 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.
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.
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.
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.
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.
Healthy Male Volunteers
Study to Investigate the Mass Balance and Biotransformation of SIM0417 in Healthy Adult Chinese Male Participants
This is a non-randomized, open-label, single-dose, Phase I clinical study to evaluate the mass balance and biotransformation, safety and tolerability of SIM0417 in healthy Chinese adult male subjects following a single oral…
- Trial name
- NCT05475834
- Testing
- SIM0417
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy Participants
A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects
This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects
- Trial name
- NCT05339646
- Testing
- SSD8432 dose 1~7 and Ritonavir, SSD8432 dose 8~9, SSD8432 dose 10~12 and ritonavir
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Bioequivalence
A Pilot Bioequivalence Study of Pomalidomide
Pomalidomide capsule were developed to offer an alternative to the marketed formulation, This pilot study was aim to pre-assess the bioequivalence of the capsule formulations under fasted condition.
- Trial name
- NCT03424928
- Testing
- Pomalidomide 4 MG Oral Capsule, Pomalidomide 4 MG Oral Capsule-Pomalyst
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Rheumatoid Arthritis (RA)
Pharmacokinetics, Safety and Tolerability Study of Single Dose of Abatacept 125mg Administered Subcutaneously
The objective of the study is to assess the single dose PK, safety, tolerability and immunogenicity of abatacept 125mg administered SC in Chinese healthy subjects.
- Trial name
- NCT02805010
- Testing
- Abatacept
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Healthy
Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of Simotinib Hydrochloride in Healthy Subjects
The purpose of this study is to assess the safety and pharmacokinetics of single ascending doses of Simotinib Hydrochloride in healthy subjects.
- Trial name
- NCT01469910
- Testing
- Simotinib Hydrochloride
- Where
- China
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.