Lishui

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and immune response (immunogenicity) of a drug called SV001 in patients diagnosed with idiopathic pulmonary fibrosis (IPF). This study is a Phase IIa clinical trial and aims to better understand how the body processes SV001 and how safe and tolerable it is for people with IPF. Participants will receive multiple doses of either SV001 or a placebo (a treatment with no active drug) during the study. The study is randomized and double-blind, meaning neither the participants nor the researchers know who receives SV001 or placebo. The dosing is planned to escalate in multiple steps to assess safety and drug behavior at different levels. During the study, participants will undergo various evaluations including monitoring for any adverse effects that arise from the treatments over approximately one year. Researchers will collect data on how the drug moves through and affects the body, immune responses, and overall safety. Participants must comply with study procedures, including using effective contraception and attending scheduled assessments throughout the study period.

Researchers are evaluating the safety and effectiveness of 9MW1911 in people with Chronic Obstructive Pulmonary Disease (COPD) through a Phase II, multicenter, double-blind, randomized, placebo-controlled clinical trial. The study focuses on patients aged 40 to 75 years who have a history of moderate to severe COPD exacerbations and moderate-to-severe COPD lung function impairment. This trial aims to compare 9MW1911 to a placebo to better understand its impact on COPD symptoms and exacerbations. Participants will be assigned to receive either intravenous 9MW1911 or a placebo every 28 days. The treatment period lasts 52 weeks, during which the study drug is administered monthly. The trial includes careful monitoring and evaluation of the participants' lung function and health status throughout this time to assess the effects of the treatment. During the study, participants will undergo various assessments including lung function tests and monitoring for COPD flare-ups or exacerbations. The primary outcome measured is the annual rate of moderate to severe acute COPD exacerbations over 52 weeks. Safety evaluations and regular health checks will also be conducted to ensure participant well-being. The total duration of participation in the trial is one year, providing comprehensive data on treatment effects and safety.

Stroke is the second leading cause of death worldwide, with ischemic stroke being the most common type. The current best treatment for acute ischemic stroke is intravenous thrombolysis using recombinant tissue plasminogen activator (rt-PA) given within 4.5 hours of symptom onset. However, some patients experience stroke progression or early blood vessel reocclusion after thrombolysis, which worsens neurological function and outcomes. This is believed to be caused by increased platelet activation after thrombolysis, which peaks within the first 2 hours. This clinical trial is testing whether starting oral aspirin early after intravenous thrombolysis can improve functional outcomes without causing more bleeding problems. Patients are randomly assigned to receive either 300 mg aspirin tablets or matching placebo tablets as soon as possible after enrollment. If swallowing is difficult, tablets can be crushed and given through a nasogastric tube. Both groups receive best medical management according to guidelines. The study is a Phase 3, multicenter, randomized, placebo-controlled trial. Participants will be followed for 90 days after stroke to measure their functional recovery using the modified Rankin scale (mRS). Researchers will check if patients have a good outcome defined as an mRS score of 0 or 1 at 90 days. During the study, patients undergo assessments including neurological exams and imaging to confirm eligibility and monitor safety. The trial aims to determine if early aspirin treatment after thrombolysis is safe and can help prevent neurological decline and improve recovery.

This research evaluates whether giving a half-dose bolus of recombinant staphylokinase (r-SAK) before primary percutaneous coronary intervention (PCI) improves outcomes in patients experiencing acute ST-segment elevation myocardial infarction (STEMI). STEMI is a serious heart condition caused by blocked coronary arteries leading to heart muscle damage. Early reperfusion treatment can reduce heart damage and improve prognosis, but it is unclear if adding thrombolytic therapy immediately before PCI within 120 minutes benefits patients. The study is a multicenter, randomized, double-blind, placebo-controlled Phase 4 trial comparing r-SAK to placebo in patients undergoing PCI within 120 minutes. Participants are randomly assigned to receive either an intravenous half-dose bolus of r-SAK or placebo within 10 minutes after STEMI diagnosis. The study focuses on facilitating PCI by potentially improving blood flow in blocked arteries through r-SAK's clot-dissolving action. The trial addresses challenges such as delays in transferring patients to PCI-capable hospitals and the risk of complications from high thrombus burden during stent placement. During the study, researchers will monitor participants for major adverse cardiovascular events (MACE) within 90 days. Assessments include clinical evaluations, ECGs, and safety monitoring to observe heart function and adverse effects. The total participation involves initial treatment and follow-up visits to track health status and treatment impact over three months.

Researchers are conducting a multicenter, randomized, double-blind, phase III clinical trial to compare the effectiveness and safety of BAT5906 injection versus Lucentis® in patients with diabetic macular edema (DME). The study plans to enroll 406 adults aged 18 to 80 years with DME involving the macular center and specific retinal thickness and visual acuity criteria. The main goal is to measure changes in best-corrected visual acuity (BCVA) over 52 weeks to evaluate whether BAT5906 is not inferior to Lucentis®. Participants are randomly assigned in equal numbers to receive either BAT5906 injection at 4.0 mg per eye or Lucentis® at 0.5 mg per eye. Both treatments are given by intravitreal injection of 50 microliters per eye. Throughout the trial, participants undergo ophthalmic examinations and safety assessments following the study protocol. Blood samples are taken to assess immune responses. The study carefully monitors treatment effects and safety for one year. During the 52-week study, participants will have scheduled visits for eye exams, visual acuity testing using the ETDRS chart, and safety evaluations. Researchers will track changes in visual acuity as the primary outcome. Safety monitoring includes detailed eye assessments and blood tests. Participants must comply with study visits and procedures, and their overall health and eye condition will be closely observed throughout the trial period.

Researchers are investigating the combination of vebreltinib and furmonertinib for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that has c-Met amplification and has progressed after EGFR-TKI treatment. The study includes a Phase Ib portion to assess safety, tolerability, and dosing, and a Phase II portion to evaluate the treatment's effectiveness, including overall response rate and progression-free survival. The Phase Ib study uses a 3+3 dose escalation design with three dose levels of vebreltinib (100 mg, 150 mg, and 200 mg twice daily) combined with furmonertinib 80 mg once daily. Following dose escalation, a dose expansion phase will enroll approximately 10 additional subjects in selected dose cohorts to determine the recommended Phase II dose. In the Phase II study, patients will receive the recommended dose of vebreltinib twice daily plus furmonertinib 80 mg once daily until disease progression or unacceptable toxicity. Participants will undergo assessments including safety monitoring, evaluation of dose-limiting toxicities, and measurement of maximum tolerated dose in Phase Ib, as well as evaluation of overall response rate in Phase II over up to 24 months. Laboratory tests, imaging, and clinical evaluations will be performed regularly to monitor disease status and adverse events throughout the study.