He Ze Shi

Researchers are evaluating TQB2934, a special antibody designed to target multiple myeloma, a cancer affecting plasma cells. This antibody binds to T cells and cancer cells to activate the immune system to attack the disease. The study is a Phase 1 clinical trial focusing on safety and the bodys handling of the drug in patients with malignant plasma cell tumors. The study involves giving TQB2934 as a subcutaneous injection at doses of 40mg or 60mg. Treatment cycles occur once weekly during the first three cycles, then every two weeks for cycles four to six. If patients achieve a partial remission or better after six cycles, dosing continues every four weeks. Each treatment cycle lasts 28 days. Participants will undergo various assessments including blood tests to measure drug levels and immune response over 120 hours after each dose. Researchers will monitor adverse events for up to 24 months and evaluate treatment responses such as remission rates and survival outcomes. The total study participation includes treatment and long-term safety follow-up lasting up to two years.

Researchers are studying the safety, tolerability, pharmacokinetics, and early effects of TQB3019 capsules in people with advanced malignant tumors. This Phase I clinical trial uses a single-center, open, non-randomized, single-arm design. The study includes two phases dose escalation and dose expansion, aiming to find appropriate dosing and assess initial responses in patients with recurrent or refractory blood cancers who have at least one measurable tumor. Participants take TQB3019 capsules orally once daily on an empty stomach, with doses ranging from 50 to 600 mg per day. Each treatment cycle lasts 28 days. The study includes both single-dose and continuous dosing regimens, with assessments made throughout these cycles to understand the drugs behavior and effects. During the trial, participants undergo regular monitoring for side effects, laboratory tests, and evaluations of tumor response. Researchers measure dose limiting toxicity, maximum tolerated dose, and recommended doses for future studies, along with overall response rates and survival outcomes up to about three years. Pharmacokinetic parameters such as drug concentration over time are monitored closely at multiple time points within each 28-day cycle to understand how the drug is processed by the body.

Researchers are evaluating the combination of baxdrostat and dapagliflozin in people with chronic kidney disease CKD and high blood pressure hypertension. This Phase III, double-blind, placebo-controlled study aims to assess whether this combination reduces the risk of serious kidney damage, heart failure events, or cardiovascular death compared to dapagliflozin alone. The study includes participants with CKD and hypertension who meet specific kidney function and blood pressure criteria. Participants who are not already taking SGLT2 inhibitors will first complete a 4-week dapagliflozin run-in period. Then, they will be randomly assigned to receive either baxdrostat plus dapagliflozin or a placebo plus dapagliflozin. Baxdrostat dosing may start low and be increased if needed. Study visits will occur at 2, 4, 8, 16, 34, and 52 weeks after randomization, and then approximately every four months until the study ends, which is based on the number of key kidney or heart-related events. Throughout the study, participants will have regular assessments including blood tests to monitor kidney function and potassium levels, blood pressure measurements, and evaluations of heart and kidney health. If participants stop the blinded study drug early, they will continue dapagliflozin if possible and remain in the study for ongoing visits and monitoring. The main outcome is whether the combination treatment reduces the risk of a 50% sustained decline in kidney function, kidney failure, heart failure events, or cardiovascular death over up to 37 months.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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 the effects of HST101 lerodalcibep, a PCSK9 inhibitor, on lowering LDL cholesterol in patients with atherosclerotic cardiovascular disease or those at very high or high risk for this condition, including patients with heterozygous familial hypercholesterolemia. This is a randomized, double-blind, placebo-controlled Phase 3 study conducted in multiple centers in mainland China to assess the safety and efficacy of HST101 over a one-year period. Participants will be randomly assigned in a 21 ratio to receive either 300 mg of HST101 or a matching placebo by subcutaneous injection every four weeks for 12 weeks. After this initial phase, all participants will receive HST101 in an open-label treatment for 36 weeks at the same dosing schedule, followed by a 4-week safety follow-up. This study includes a screening period lasting up to 3 weeks before treatment begins. During the study, participants will have regular assessments to monitor LDL cholesterol changes, free PCSK9 levels, other lipid parameters, and any treatment-related side effects. The primary focus is the change in LDL cholesterol at week 12 compared to placebo. Safety and efficacy will be observed throughout the 52-week treatment period, including monitoring for adverse events. The total study duration for participants is up to 55 weeks, including screening and follow-up.

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 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.

Researchers are conducting a multi-center observational study to develop and assess the accuracy of fecal multi-marker panels for screening gastrointestinal cancers, specifically gastric and colorectal cancers. The study aims to evaluate the sensitivity and specificity of stool-based biomarker testing compared to baseline endoscopic screening. This research will help determine how well these stool tests can identify gastrointestinal cancers early. Participants scheduled for gastroscopy and colonoscopy will provide a stool sample before their endoscopic procedures. These samples will undergo qualitative and quantitative Fecal Immunochemical Tests FIT along with novel biomarker testing. After the initial endoscopic screening, participants will be followed for two years to monitor outcomes and assess the screening tests performance. During the study, participants will have stool samples collected before their endoscopy appointments. Data from these tests will be compared to the results of their endoscopic examinations conducted about two weeks later. Researchers will focus on measuring the sensitivity and specificity of the fecal biomarker tests for cancer screening. The two-year follow-up will provide additional information on the tests effectiveness and participants health outcomes throughout this period.

Researchers are evaluating the safety of F573 for injection in patients with various types of liver injury, including drug-induced liver injury DILI, chronic hepatitis B CHB, and intrahepatic cholestatic liver injury. This Phase II randomized, double-blind, placebo-controlled clinical trial aims to understand how F573 affects patients at risk of liver failure due to these injuries. The study is conducted in multiple stages. In the first stage, 25 patients receive different doses of F573 or a placebo via intramuscular injection once daily for 7 days. The second stage enrolls 24 patients treated with F573 or placebo at two dose levels once daily for 14 days. The third stage involves a 28-day treatment period with daily intramuscular injections of F573 or placebo, alongside acetylcysteine injection as basic treatment. Dosages are adjusted based on patient weight and earlier trial results. Participants undergo a screening period of 14 days before treatment and a follow-up period of 90 days after treatment completion. Throughout the study, patients receive various assessments including laboratory blood and urine tests, vital sign monitoring, physical exams, electrocardiograms, liver ultrasounds, and biomarker evaluations. Researchers monitor for adverse events, liver function scores, survival status, and medication use to evaluate safety and effects of the treatment.