Fu Xin Shi

Researchers are conducting a Phase III study to evaluate the safety, tolerability, dose-limiting toxicity DLT, maximum tolerated dose MTD, and recommended Phase II dose RP2D of WJB001 capsules in patients with advanced solid tumors. The study includes multiple phases dose escalation, dose expansion, and cohort expansion, aiming to understand the drugs initial efficacy, safety, and pharmacokinetic characteristics. During the dose escalation phase, accelerated titration was used for the first two dose groups, followed by a Bayesian optimal interval BOIN combination method for later dose groups. In the dose expansion phase, one to two doses were selected based on previous data to confirm the RP2D and further evaluate efficacy and safety. The cohort expansion phase plans to expand two to three patient groups using the Simon two-stage optimal method. Participants will undergo screening, treatment, and follow-up periods. Researchers will assess dose-limiting toxicities over 21 days and monitor adverse events, serious adverse events, objective response rate, and survival outcomes for up to three years. Pharmacokinetic measurements including peak time, plasma concentration, clearance rate, and half-life will be collected at specific time points during treatment cycles. This extensive monitoring aims to understand WJB001s effects and determine appropriate dosing for future studies.

Researchers are evaluating the safety, pharmacokinetics, and effectiveness of a drug called QD202 in adults with acute ischemic stroke who are receiving thrombolysis but not endovascular thrombectomy. This randomized, double-blinded, placebo-controlled phase II trial aims to better understand how QD202 works and is tolerated in this patient group. The study is sponsored by Shanghai QuietD Biotechnology Co., Ltd. and will include up to 120 male and female participants aged 18 to 85 years. Participants will be randomly assigned to one of three groups two experimental groups receiving different doses of QD202 100 mg on Day 1 followed by either 5 mg or 10 mg daily from Day 2 to Day 5 or a placebo group receiving a matching placebo daily for five days. The study drug or placebo is given as a 60-minute intravenous infusion after completion of thrombolysis. The trial includes a treatment period of five days and follow-up visits on Day 7 or discharge day, Day 30, and Day 90. During the study, participants will undergo assessments including stroke severity scales such as the National Institutes of Health Stroke Scale NIHSS, functional outcome measures like the modified Rankin Scale mRS and Barthel Index BI, and blood tests to monitor drug levels and safety. Safety and tolerance will be followed through Day 90. Participants will have multiple visits during this period for evaluations of their neurological status and overall health.

Researchers are evaluating the safety and effectiveness of Yangxinshi tablets in patients with coronary heart disease combined with cardiac dysfunction. This study aims to determine if adding Yangxinshi tablets to standard treatment can reduce heart-related events, enhance exercise capacity, and improve quality of life and mental health. The trial includes 2708 patients and is a Phase 4 randomized controlled study sponsored by SPH Qingdao Growful Pharmaceutical Co., Ltd. Participants are randomly assigned to one of two groups one group receives conventional treatment plus Yangxinshi tablets 3 tablets taken orally three times a day, while the control group receives conventional treatment alone. Conventional treatment includes drugs such as aspirin, beta-blockers, statins, and others for symptom relief and improving heart outcomes. The treatment continues until a set number of heart-related events occur or the study ends. Throughout the study, participants undergo regular assessments including measurements of heart events, exercise tolerance, heart function tests, blood markers, and mental health questionnaires over an average of three years. Additional evaluations at 24 and 48 weeks include depression and anxiety scales, echocardiography, and exercise testing. The research team closely monitors safety, quality of life, and heart function throughout the study period.

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.