Qingyuan

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 HER2 positive tumor cells, in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study aims to assess the safety and effectiveness of TQB2102 in this patient population, addressing the need for new treatments after unsuccessful platinum-based chemotherapy. Participants will receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. This investigational drug combines a humanized antibody with a potent drug payload to specifically attack tumor cells. The study includes monitoring for adverse events and anti-drug antibodies during treatment and follow-up. During the trial, participants will undergo regular assessments including tumor measurements to evaluate overall response rate, duration of remission, progression-free survival, overall survival, and disease control rate for up to 12 to 17 months. Safety evaluations will continue until 28 days after the last dose or the start of new cancer therapies. Blood samples for anti-drug antibody testing will be collected at specific treatment cycles and after treatment completion. The total involvement period depends on individual treatment duration and follow-up schedules.

Researchers are evaluating the safety and effects of a medicine called fosmanogepix for treating candidemia and invasive candidiasis, which are serious fungal infections caused by Candida yeast. This Phase 3 clinical trial compares fosmanogepix to the standard treatment using caspofungin followed by fluconazole, aiming to show that fosmanogepix is not worse than the standard treatment by a margin of 15%. The study includes adult patients diagnosed with these infections and is sponsored by Basilea Pharmaceutica. Participants are randomly assigned to one of two groups two-thirds receive fosmanogepix intravenously, with an option to switch to oral tablets, while one-third receive caspofungin intravenously followed by oral fluconazole. Matching placebos are given to maintain blinding. Treatments are given daily, first by IV infusion at the clinic and then orally either at the clinic or at home if discharged. Treatment duration can be up to six weeks, depending on infection clearance and symptom improvement. Participants will be monitored through multiple study visits, with assessments including survival status at 30 days, treatment success at the end of treatment, and follow-up evaluations six weeks after stopping treatment. Additional evaluations include clinical and mycological responses, blood cultures, safety monitoring such as adverse events, lab tests, neurological exams, ECGs, and drug concentration measurements. The total study duration for each participant may be approximately 12.5 weeks, considering treatment and follow-up periods.

Chronic kidney disease CKD involves damage to the kidneys structure or function and affects a significant portion of the population in China, with a prevalence of 10.8%. CKD not only leads to severe kidney failure requiring treatments like dialysis but also raises the risk of cardiovascular diseases, placing a heavy burden on individuals and the healthcare system. This research aims to improve understanding of CKD occurrence, progression, treatment, prognosis, and risk factors in the Chinese population through a large-scale, real-world observational study. The study is a multi-center, prospective observational registry involving participants from various centers across mainland China. It collects and integrates standardized data to efficiently analyze CKD patterns and outcomes. The study includes both CKD patients and individuals with risk factors such as hypertension, diabetes, or hyperlipidemia, as well as healthy participants, to allow broad representation and subgroup analysis. The study is designed to cover a large sample size and account for potential loss to follow-up. Participants will be observed over up to 5 years to monitor the development of CKD in non-CKD individuals and the progression of disease in those with CKD. Researchers will track changes in kidney function, albuminuria levels, and composite endpoints including disease progression and mortality. Data collection includes clinical assessments and laboratory measurements to evaluate disease markers and outcomes. The study offers long-term monitoring to better understand CKD dynamics and inform prevention and control strategies.

Researchers are evaluating the effects of a triple therapy inhaler combining budesonide, glycopyrronium, and formoterol fumarate BGF MDI 32014.49.6 g compared to a dual therapy inhaler with glycopyrronium and formoterol fumarate GFF MDI 14.49.6 g on heart and lung outcomes in adults with Chronic Obstructive Pulmonary Disease COPD who have a higher risk for heart and lung events. This Phase III study is randomized, double-blind, and conducted at multiple centers, focusing on participants with COPD and elevated cardiopulmonary risk. Participants will receive either the triple therapy inhaler or the dual therapy inhaler, both administered twice daily. The study compares these two inhalers over a period of up to three years, monitoring for serious cardiac or COPD events. The trial includes careful evaluation of various heart and lung-related health events during this period. During the study, participants will be closely monitored through regular visits, assessments, and tests to measure lung function, heart events, and COPD exacerbations. Researchers will track the time until the first severe cardiac or COPD event and evaluate other cardiovascular and respiratory outcomes over up to three years. Participants will also be assessed for their ability to properly use the inhaler and adherence to the study protocol throughout the trial.

Researchers are evaluating BBT002, a drug being studied to assess its safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics, and clinical activity in both healthy volunteers and people with Chronic Obstructive Pulmonary Disease COPD. The study is a randomized, double-blind, placebo-controlled trial conducted in two parts, including single and multiple ascending dose evaluations. This research aims to understand how BBT002 behaves in the body and its effects over time in these groups. The trial has two parts Part A involves administering a single dose of BBT002 or placebo to healthy volunteers in sequential dose groups. Part B involves giving two repeated doses of BBT002 or placebo to participants with COPD. Each participant will receive either the study drug or placebo depending on their group assignment. The study monitors responses to both single and multiple doses, with treatments given under close medical supervision. Participants will undergo assessments including monitoring for adverse events, laboratory tests, vital sign checks, physical exams, and electrocardiograms ECGs up to 141 days after dosing in healthy volunteers and up to 169 days in COPD patients. Pharmacokinetic measurements such as drug concentration and clearance will be collected at specified times. The study also tracks immune responses to the drug. Overall participation involves multiple visits and evaluations over several months to ensure comprehensive safety and activity data.

Researchers are evaluating vedolizumab, given as an intravenous infusion, as a treatment for adults in China with moderate to severe Crohns Disease. This Phase 3 study aims to assess the safety and effectiveness of vedolizumab compared to a placebo. Approximately 408 participants will take part, and the study is sponsored by Takeda. Participants will be randomly assigned to receive either vedolizumab 300 mg or a placebo intravenously at Weeks 0, 2, and 6 during the 14-week Induction Period. After Week 14, all participants continue in an open-label extension phase where they receive vedolizumab 300 mg every 8 weeks until Week 54 or 58. Those who do not respond or whose disease worsens after Week 18 may receive vedolizumab every 4 weeks. This treatment schedule includes up to 20 study visits over about 58 weeks. During the study, participants will undergo various assessments including clinical response evaluations at Week 14, endoscopic exams, and monitoring for adverse events up to 18 weeks after the last dose. Safety follow-up visits and a long-term safety survey by telephone will occur up to 6 months post-treatment. The main outcome measured is the percentage of participants achieving a clinical response at Week 14, with other measures including remission rates and safety lab results over the study period.

Researchers are evaluating the effectiveness and safety of a new drug called GSK3862995B in adults with bronchiectasis, a chronic lung disease. This Phase 2 study also examines how the body processes the drug and checks for any immune reactions. Participants will be randomly assigned to receive one of two doses of GSK3862995B or a placebo to compare their effects on bronchiectasis. Participants will receive either Dose Level 1 or Dose Level 2 of GSK3862995B, or a matching placebo. The study uses a double-blind, randomized design, meaning neither participants nor researchers know who gets which treatment. The treatment period lasts up to 48 weeks, during which participants receive repeated doses. The study also includes assessments up to 72 weeks to monitor safety and immune responses. During the trial, participants will undergo evaluations including lung function tests, quality-of-life questionnaires, and monitoring of respiratory symptoms. Researchers will track the number of lung exacerbations, serious adverse events, laboratory tests, vital signs, and electrocardiograms to assess safety and effectiveness. Participants will be involved in regular visits and assessments throughout the treatment and follow-up periods, lasting up to about 72 weeks in total.

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.

Researchers are evaluating the effectiveness and safety of AHB-137 injection in adults aged 18 to 65 with chronic hepatitis B who have not previously received treatment. This randomized, double-blind, placebo-controlled, multicenter phase 2 study aims to compare AHB-137 with a placebo to better understand its impact on the disease. Participants will receive either AHB-137 or a placebo through subcutaneous injections. The study involves monitoring viral markers such as HBV DNA and HBsAg levels during and after treatment. The treatment period and follow-up last up to 48 weeks, during which multiple virological, serological, and safety assessments will be conducted. Throughout the study, participants will undergo regular evaluations including laboratory tests for viral load and liver function, measurement of quality of life, and monitoring for adverse events. The researchers will track the proportion of participants achieving certain virological milestones and seroconversion rates. Safety assessments and drug concentration measurements will also be performed. The total participation duration extends through treatment and post-treatment observation up to 48 weeks.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease COPD. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.