Clinical trials: sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.
Psoriasis
Evaluate the Safety and Pharmacokinetics/Pharmacodynamics of HS-20118
The study will be conducted in 2 parts (SAD for Part 1 and MAD for Part2). Part 1 is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability, immunogenicity, and PK of…
- Trial name
- NCT06846710
- Testing
- HS-20118
- Where
- 9 sites in United States, New Zealand
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
SCHIZOPHRENIA 1 (Disorder)
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
This is a Phase 3, randomized, double-blind, parallel-group, active- and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a…
- Trial name
- NCT07911787
- Testing
- HS-10380, Aripiprazole
- Where
- China
- Volunteers
- 476 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Advanced or Metastatic NSCLC
Phase III Study of HS-10504 Versus Platinum-Based Doublet Chemotherapy in Patients With C797S+ NSCLC
This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of oral HS-10504 monotherapy versus platinum-based doublet chemotherapy in participants with locally…
- Trial name
- NCT07754123
- Testing
- HS-10504, platinum-based doublet chemotherapy (Pemetrexed and Cisplatin/Carboplatin)
- Where
- China
- Volunteers
- 206 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy Participants
A Study to Evaluate the Pharmacokinetic Characteristics of HS-20118 Under Different Dosing Conditions in Healthy Participants
This study is a single-center, open-label, randomized, four-period dosing clinical study designed to evaluate the pharmacokinetic characteristics of HS-20118 under different dosing conditions in healthy participants.
- Trial name
- HS-20118-111 (NCT07896915)
- Testing
- HS-20118
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Chronic Myeloid Leukemia
A Study of HS-10382 Versus Investigator-selected TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP
This trial is a multicenter, open label, randomized phase III clinical study that evaluates the efficacy of oral HS-10382 versus investigator selected TKIs (imatinib, nilotinib, dasatinib, and flumatinib) in newly diagnosed…
- Trial name
- NCT07885293
- Testing
- HS-10382, Imatinib, Dasatinib
- Where
- China
- Volunteers
- 408 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hepatic Impairment (Moderate or Mild) & Normal Hepatic Function
A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of HS-10506
Moderate Hepatic Impairment Study Phase This phase employs a multicenter, open-label, parallel-group, single-dose study design.Two cohorts are established in this phase: Cohort A: Subjects with moderate hepatic impairment Cohort…
- Trial name
- HS-10506-114 (NCT07844967)
- Testing
- HS-10506
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
To Compare the Pharmacokinetic (PK) Differences of HS-10504 Between Participants With Hepatic Impairment and Participants With Normal Hepatic Function
A Pharmacokinetic Study of HS-10504 in Participants With Hepatic Impairment and Normal Hepatic Function.
This is a two-part single-center, open-label, parallel, single-dose pharmacokinetic study of HS-10504 in participants with hepatic impairment and normal hepatic function.
- Trial name
- NCT07836504
- Testing
- HS-10504
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Carcinoma, Non-Small-Cell Lung
A Study Evaluating HS-10370 Plus Platinum-based Doublet Chemotherapy With or Without Adebrelimab vs. Tislelizumab Plus Chemotherapy as First-Line Therapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
This is a trial to evaluate the efficacy, safety, and tolerability of HS-10370 in combination with Platinum-based Doublet Chemotherapy With or Without Adebrelimab Versus Tislelizumab Plus Platinum-based Doublet Chemotherapy as…
- Trial name
- NCT07822542
- Testing
- HS-10370, Adebrelimab, Cisplatin
- Volunteers
- 448 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
High-risk Non-muscle-invasive Bladder Cancer
A Study of HS-10566 in Patients With High-risk Non-muscle-invasive Bladder Cancer Who Are Ineligible for or Refuse Radical Cystectomy
This is a multicenter, open-label, Phase I/II clinical study evaluating the safety, efficacy, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) profiles of HS-10566 in patients with high-risk non-muscle-invasive bladder…
- Trial name
- NCT07468851
- Testing
- HS-10566
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Locally Advanced or Metastatic NSCLC
A Study of HS-10504 in Patients With Advanced or Metastatic Non-Small-Cell Lung Cancer(NSCLC)
HS-10504 is a fourth-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor targeting EGFR C797S mutation.
- Trial name
- NCT06461156
- Testing
- HS-10504
- Where
- China
- Volunteers
- 230 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Dyslipidemia
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10582 in Healthy Subjects and Subjects With Mildly Elevated LDL-C Levels
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10582 following single and multiple dose administration to healthy subjects and subjects with Mildly Elevated LDL-C.
- Trial name
- NCT07777003
- Testing
- HS-10582
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy Participants
A Phase I Clinical Trial to Evaluate Pharmacokinetics of HS-10504
This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.
- Trial name
- NCT07770217
- Testing
- HS-10504, Rifampin
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy Subjects
A Mass Balance Study of [14C]HS-10504
This study is a single-site, non randomized, open-label study to assess the absorption, metabolism, and excretion profile of [14C] HS-10504 in healthy adult male subjects.
- Trial name
- NCT07764705
- Testing
- [¹⁴C]HS-10504
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Moderate to Severe Plaque Psoriasis
A Phase 2 Study of HS-20118 to Evaluate the Efficacy and Safety in Participant With Moderate-to-Severe Plaque Psoriasis
The primary objective of this study is to evaluate the efficacy of HS-20118 compared with placebo in participants with moderate to severe plaque psoriasis.
- Trial name
- NCT07765628
- Testing
- HS-20118
- Volunteers
- 120 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy Participants
A Phase I Clinical Trial to Evaluate the Effect of Itraconazole on the Pharmacokinetics of HS-10504
This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.
- Trial name
- NCT07764692
- Testing
- HS-10504, Itraconazole Capsules
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
SCHIZOPHRENIA 1 (Disorder)
A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia
The primary purpose of this open-label phase 3 study is to evaluate the safety of HS-10380 on the incidence, severity, relationship to investigational product of adverse events (AE), serious adverse events (SAE), and adverse…
- Trial name
- NCT07759869
- Testing
- HS-10380
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Obesity
A Phase I Study of Single and Multiple Doses of HS-20136-2 Injection in Healthy or Obese Participants
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-20136-2 injection in healthy/obese participants.
- Trial name
- NCT07716241
- Testing
- HS-20136-2
- Where
- China
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
NSCLC
An Open-label, Fixed-sequence Phase I Clinical Trial to Evaluate the Effect of HS-10504 on the Pharmacokinetics of Midazolam in Patients With Non-small Cell Lung Cancer
This is an open-label, fixed-sequence Phase I clinical trial to evaluate the effect of HS-10504 on the pharmacokinetics of midazolam (CYP3A4 substrate) in patients with EGFR mutation-positive locally advanced or metastatic…
- Trial name
- NCT07685041
- Testing
- HS-10504； midazolam
- Volunteers
- 24 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Insomnia Disorder
A Study to Evaluate the Safety of HS-10506 in Chinese Patients With Insomnia Disorder
The primary purpose of this open-label phase Ⅲ study is to evaluate the safety of HS-10506 on the incidence and severity of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI) in Chinese…
- Trial name
- NCT07677384
- Testing
- HS-10506
- Volunteers
- 600 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Overweight, Obesity
A Study of HS-20094 in Chinese Adults With Overweight or Obesity
The main purpose of this study is to assess the Efficacy and safety of HS-20094 in overweight and obese patients. The study will last up to approximately 52 weeks.
- Trial name
- NCT06839664
- Testing
- HS-20094 injection
- Where
- China
- Volunteers
- 604 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.