Lishui

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and immune response of a drug called SV001 in patients with idiopathic pulmonary fibrosis IPF, a lung condition. This Phase IIa clinical trial is randomized, double-blind, and placebo-controlled, aiming to gather detailed information about how the drug behaves in the body and its safety profile. Participants will receive multiple doses of SV001 or a placebo, with the study designed to compare these groups. The treatment period includes escalating doses to assess how the drug is tolerated and processed by the body. The study will last approximately one year, during which participants will be closely monitored. During the trial, participants will undergo regular assessments including checking for treatment-related adverse events, measuring the drug concentration in blood over time, and testing for immune responses. The main outcome is the incidence of adverse events over about one year. Additional evaluations will look at peak drug levels, time to peak levels, drug exposure over time, half-life, and immunogenicity. Safety and tolerability will be continuously monitored throughout the study period.

Researchers are evaluating 9MW1911 in adults aged 40 to 75 who have been diagnosed with Chronic Obstructive Pulmonary Disease COPD for at least one year. This Phase II clinical trial is designed to assess how well 9MW1911 works and how safe it is for treating COPD. The study compares two different doses of 9MW1911 given intravenously with a placebo, and aims to better understand treatment effects on COPD flare-ups and lung function. Participants receive intravenous infusions of either 9MW1911 in one of two dose levels or a placebo every 28 days. Each treatment group includes 120 patients, all receiving stable standard care for COPD. The study lasts for 52 weeks of treatment, followed by safety and immune response monitoring up to 60 weeks. Researchers measure lung function, COPD exacerbations, quality of life, and other health markers during this period. During the study, participants will have regular visits for lung function tests, questionnaires about COPD symptoms and quality of life, blood tests, and safety assessments. These assessments occur at multiple time points, such as weeks 0, 4, 8, 12, 24, 36, and 52. The main outcome is the rate of moderate to severe COPD exacerbations over one year. Additional measures include lung function changes, time to first exacerbation, and biological markers. Safety and tolerability are followed for up to 60 weeks to ensure participant well-being throughout the trial.

Acute ischemic stroke is a leading cause of death worldwide, and intravenous thrombolysis with recombinant tissue plasminogen activator rt-PA within 4.5 hours of symptom onset is the most effective treatment currently available. However, some patients experience stroke progression and early reocclusion after thrombolysis, which can worsen neurological outcomes. This trial evaluates whether early antiplatelet therapy with oral aspirin, given soon after thrombolysis, can improve recovery without increasing bleeding risks. The study randomly assigns patients to receive either early oral aspirin within 3 hours of starting intravenous thrombolysis or a placebo, alongside the best medical care based on current guidelines. Aspirin is administered as a 300 mg dose, either chewed or given via nasogastric tube if swallowing is difficult. The trial includes a control group receiving placebo under similar conditions to compare outcomes. This is a Phase 3, multicenter, quadruple-blind, randomized clinical trial. During the study, participants will be closely monitored for neurological status and functional recovery using the modified Rankin scale at 30 and 90 days after stroke, as well as other assessments like NIH Stroke Scale scores within the first week. Researchers will track early neurological changes and safety outcomes such as intracranial hemorrhage. Follow-up will include evaluations at multiple time points up to 90 days post-stroke to determine the effects of early antiplatelet treatment on stroke recovery.

Researchers are evaluating whether adding a half-dose bolus of recombinant staphylokinase r-SAK, a clot-dissolving drug, immediately before primary percutaneous coronary intervention PCI can improve outcomes in patients with acute ST-segment elevation myocardial infarction STEMI treated within 120 minutes. This randomized, double-blind, placebo-controlled trial aims to assess the safety and efficacy of r-SAK in reducing major adverse cardiovascular events within 90 days after treatment. Participants are randomly assigned to receive either a single intravenous bolus of 5 mg r-SAK over 3 minutes or a placebo injection within 10 minutes after STEMI diagnosis. Following this, all patients undergo primary PCI within 30 to 120 minutes. The study is conducted across multiple centers and compares the effects of r-SAK versus placebo as adjunctive therapy before PCI. During the study, participants will be monitored for major adverse cardiovascular events up to 90 days, with additional assessments including cardiac and cerebrovascular events, blood biomarkers NT-proBNP, cardiac imaging by echocardiogram and cardiac magnetic resonance imaging CMR, and blood flow in coronary arteries immediately before and after PCI. Safety and efficacy will also be tracked up to one year. The total participation duration includes follow-up visits at days 7, 90, and 360 after treatment.

Researchers are evaluating the efficacy and safety of BAT5906 compared to Lucentis in people with diabetic macular edema DME. This multicenter, randomized, double-blind trial plans to enroll 406 participants aged 18 to 80 years who have DME affecting the central part of the retina. The primary goal is to assess changes in best-corrected visual acuity BCVA from the start of the study to week 52 using the ETDRS chart. Participants are randomly assigned to receive either BAT5906 or Lucentis through intravitreal injections directly into the eye. Each treatment is given once every 4 weeks for three doses, followed by monitoring visits every 4 weeks with possible additional doses as needed, continuing through week 52. BAT5906 is administered at 4.0 mg per eye, while Lucentis is given at 0.5 mg per eye. Throughout the study, participants undergo regular eye exams, safety assessments, and blood tests to monitor immune response. Researchers measure visual acuity changes to determine treatment effects. The study includes ongoing safety monitoring and assessments until week 52 to evaluate both treatments effectiveness and safety in managing DME.

Researchers are evaluating the combination of vebreltinib and furmonertinib in patients with locally advanced or metastatic non-small cell lung cancer NSCLC who have c-Met amplification and have experienced failure of prior EGFR-TKI treatment. This study includes both a Phase Ib and a Phase II clinical trial. The Phase Ib study aims to determine the maximum tolerated dose MTD, dose-limiting toxicities DLT, and the recommended Phase II dose RP2D of vebreltinib combined with furmonertinib. The Phase II study will assess the efficacy of this combination by measuring outcomes such as overall response rate ORR and progression-free survival PFS. The Phase Ib study involves two stages dose escalation and dose expansion. Dose escalation uses a 33 design with vebreltinib doses of 100 mg, 150 mg, and 200 mg taken twice daily, combined with furmonertinib at 80 mg once daily. Dose escalation decisions depend on the occurrence of DLTs within 28 days. The dose expansion stage will enroll approximately 10 additional patients per selected dose level to confirm safety and determine the recommended dose for Phase II. In the Phase II study, participants will receive the recommended dose of vebreltinib twice daily along with furmonertinib 80 mg once daily until disease progression or intolerable side effects occur. During the study, participants will undergo various assessments including tumor evaluations based on RECIST v1.1 criteria, laboratory tests, and safety monitoring. The primary outcomes include incidence of DLTs, determination of MTD and RP2D in Phase Ib, and ORR in Phase II. Secondary outcomes include progression-free survival, duration of response, disease control rate, overall survival, adverse events, and health-related quality of life. The total observation period for some outcomes extends up to five years, with active treatment continuing until disease progression or unacceptable toxicity.

Researchers are evaluating treatments for adults with acute spontaneous supratentorial intracerebral hemorrhage ICH of 20mL or more. This trial compares early minimally invasive surgery combined with thrombolysis eMIST to best medical management. The goal is to assess which approach improves functional outcomes after stroke, measured by a blinded evaluation at 180 days using the modified Rankin Scale. Participants are randomly assigned to one of two groups one receives minimally invasive catheter evacuation followed by up to 10 doses of urokinase to help dissolve the clot the other group receives standard medical care. The intervention is given early after stroke onset, with randomization within 8 hours and treatment started within 4 hours after randomization. The study uses an adaptive design with ongoing assessment of sample size and outcomes. During the study, participants undergo assessments including brain imaging, functional outcome scales, and quality of life questionnaires at multiple time points up to 180 days. Researchers will monitor clot removal, mortality, daily living activities, and health-related quality of life. The trial includes follow-up visits to evaluate recovery and safety over time, supporting a thorough understanding of treatment effects and participant progress.