He Ze Shi

Researchers are evaluating TQB2934, a special antibody designed to treat multiple myeloma, a type of malignant plasma cell tumor. TQB2934 is a double-specific antibody that binds to both the CD3 receptor on T cells and the BCMA antigen on cancerous plasma cells. This binding helps recruit and activate T cells to attack and kill the cancer cells. The study is a Phase 1 clinical trial focusing on the safety and pharmacokinetics of this treatment in adults with multiple myeloma. The treatment involves subcutaneous injections of TQB2934. The antibody works by activating T cells to release substances that kill BCMA-positive target cells. The study monitors participants over time to assess how the drug is processed in the body, including measures like peak drug concentration and elimination half-life within 120 hours after administration. The trial also tracks adverse events for up to 24 months. Participants will undergo various laboratory tests and assessments to meet study requirements and monitor their health throughout the trial. Researchers will evaluate pharmacokinetics, including peak time, drug concentration, and clearance, as well as safety by recording any adverse events. The study includes careful monitoring of participants' condition and treatment responses, with follow-up lasting up to two years to ensure comprehensive safety data collection.

Researchers are evaluating TQB3019 capsules, a targeted protein degrader, for safety, tolerability, pharmacokinetics, and preliminary effectiveness in people with advanced malignant tumors. This Phase I clinical trial uses a single-center, open, non-randomized, single-arm design and includes patients with recurrent or refractory hematological tumors who have measurable disease and good organ function. The trial is divided into two phases: dose escalation and dose expansion. Participants receive TQB3019 capsules orally in either a single-dose or continuous dosing regimen. The study monitors dose limiting toxicity, maximum tolerated dose, recommended Phase II dose, and maximum assessed dose. The trial also tracks adverse events and serious adverse events from the first dose up to 28 days after the last dose or until other anti-tumor treatment begins, with follow-up lasting up to about three years. Participants will undergo multiple evaluations including safety and response assessments during each 28-day treatment cycle. Researchers will monitor laboratory test results and overall response rate from the first dose until disease progression or death. Safety and tolerability are carefully observed over extended periods to understand the drug's effects. The total participation duration can last up to approximately three years depending on treatment and follow-up.

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study. Participants who fulfill the inclusion and exclusion criteria will be enrolled at up to 35 study sites in mainland China. All eligible participants will be randomized in a 2:1 ratio to HST101 or placebo dosed subcutaneously (Q4W \[≤31 days\]) in the initial 12-week randomized double-blind treatment period. After 12-week treatment, all the participants will enter to the 36-week open-label treatment period where those who are on HST101 will continue to receive HST101 in the same dosing regimen as dosed in the randomized period, and those who are on placebo will be switched to HST101 300 mg (Q4W \[≤31 days\]) administered subcutaneously. The total study duration will be up to 55 weeks which includes a up to 3-week Screening Period, 12-week randomized, double-blind, placebo-controlled treatment period, 36-week open-label treatment period, followed by a 4-week follow-up 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.

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). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the effectiveness and safety of AL2846 capsules combined with TQB2450 injection compared to docetaxel injection in patients with advanced non-small cell lung cancer (NSCLC) who have not responded to previous immunotherapy treatments. This phase III, multicenter, randomized, double-blind study focuses on patients with inoperable locally advanced, metastatic, or recurrent NSCLC who have failed platinum-based chemotherapy and immune checkpoint inhibitors. The study aims to assess overall survival up to 36 months after randomization. The study compares two treatment groups: one receiving AL2846 capsules, a multi-targeted small molecule receptor tyrosine kinase inhibitor, combined with TQB2450 injection, an anti-PD-L1 therapy; and the other receiving docetaxel injection, a chemotherapy drug, with matching placebos for AL2846 and TQB2450. Treatment is administered according to the study protocol, with patients monitored throughout the trial period. Participants will undergo assessments including evaluation of tumor lesions using RECIST 1.1 criteria and monitoring of major organ function. The study tracks overall survival from the time of randomization until death from any cause for up to 36 months. Safety and adverse events will be closely observed to ensure participant well-being during the trial.

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 randomized, double-blind, placebo-controlled Phase 1a clinical trial includes patients aged 18 to 60 years and aims to assess safety and tolerability in these liver conditions. The study is divided into three stages. In the first stage, 25 patients receive different doses of F573 or placebo via intramuscular injection once daily for 7 days, with doses ranging from 0.5 to 2.0 mg/kg. The second stage enrolls 24 patients who receive either 0.5 mg/kg or 2.0 mg/kg doses or placebo once daily for 14 days. The third stage involves a 14-day screening period, a 28-day treatment period where patients receive F573 or placebo daily plus acetyl cysteine injection, followed by a 90-day safety follow-up. Dosing is calculated based on patient weight and determined by earlier phase results. Participants undergo clinical laboratory tests including blood routine, blood biochemistry, urine routine, blood coagulation, and 12-lead electrocardiograms during and after treatment. Researchers also monitor adverse events, vital signs, physical exams, abdominal and cardiac ultrasounds, biomarker tests, liver scores (MELD and AARC), survival status, and medication use. Follow-up periods extend up to 90 days after dosing to assess safety and mortality outcomes.