Zun Yi Shi

Researchers are evaluating the effectiveness and safety of B007 in people with generalized myasthenia gravis, a condition that causes muscle weakness. This randomized, double-blind, placebo-controlled Phase IIIII study aims to understand how well B007 works compared to a placebo in improving daily living activities affected by this condition. Participants will receive either a high or low dose of B007 or a matching placebo through subcutaneous injections on days 1 and 15. The study includes careful monitoring over approximately 16 to 24 weeks to assess changes in symptoms and quality of life, with a safety follow-up lasting about one year. During the trial, participants will be evaluated through various measures including the Myasthenia Gravis-Activities of Daily Living profile, quality of life questionnaires, and composite scores related to the condition. Researchers will also track any side effects or adverse events. The total participation time varies, with key assessments occurring around 16 to 24 weeks and safety monitored for about a year.

Researchers are evaluating TQB2102, an antibody-drug conjugate designed to target Human Epidermal Growth Factor Receptor 2 HER2 in patients with locally advanced or metastatic non-small cell lung cancer who have HER2 gene abnormalities. This Phase 2 study aims to assess the effectiveness and safety of TQB2102, which combines targeted antibody action with a potent drug payload that is normally too toxic for general use. Participants receive TQB2102 through intravenous infusion every three weeks, with each treatment cycle lasting 21 days. Some participants will receive TQB2102 alone, while others will receive TQB2102 combined with Benmelstobart, another intravenous drug targeting programmed death ligand-1 PD-L1. Both treatments are given over multiple cycles to evaluate their effects. During the study, participants will be closely monitored through various assessments including measuring tumor response over up to eight months, tracking survival, and recording any adverse events from the start of treatment until 28 days after the last dose. Researchers will also check for immune responses to the drug at several points during and after treatment. The total participation may last up to 18 months to gather comprehensive safety and effectiveness data.

Researchers are evaluating the efficacy and safety of TQH3906, a Tyrosine Kinase 2 TYK2 inhibitor, in treating systemic lupus erythematosus SLE, an autoimmune disease. This randomized, double-blind, placebo-controlled, multi-center Phase II clinical trial aims to assess how well TQH3906 works and its safety profile in adults diagnosed with SLE based on established criteria. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Participants are randomly assigned to one of three groups 16 mg TQH3906 capsule, 24 mg TQH3906 capsule, or placebo. All treatments are taken orally once daily for 48 weeks. The trial compares these doses to placebo to understand TQH3906s impact on disease activity. The study uses a parallel design and includes a quadruple masking method to keep participants and researchers unaware of group assignments. During the study, participants undergo regular assessments including clinical evaluation of disease activity using the Systemic Lupus Erythematosus Responder Index 4 SRI-4, lupus activity indices, and joint assessments up to week 48. Safety is monitored throughout, and background lupus medications must remain stable during the trial. The primary outcome measure is the percentage of participants achieving SRI-4 response by week 32, with additional secondary measures assessing remission, low disease activity, and symptom improvements. Participation lasts up to 48 weeks with scheduled visits and monitoring.

Researchers are evaluating the efficacy and safety of elecoglipron, an oral tablet taken once daily, for weight management in adults with obesity or overweight. This Phase III global, randomized, double-blind, placebo-controlled trial includes two independent pivotal studies one in adults without type 2 diabetes T2DM and the other in adults with T2DM, all having at least one weight-related health condition. The goal is to understand how elecoglipron compares to placebo when combined with diet and exercise. Participants will be randomly assigned to receive either one of two doses of elecoglipron or a matching placebo daily. Study 1 involves about 3000 adults living with obesity or overweight without T2DM, while Study 2 involves about 1500 adults with obesity or overweight and T2DM. Both studies last 72 weeks, during which changes in body weight and other health measures will be monitored. During the trial, participants will undergo regular health assessments including measurements of body weight, waist circumference, blood sugar control, blood pressure, and other related health indicators. Researchers will track percent change in body weight from baseline at 72 weeks as the primary outcome. Participants will be monitored closely throughout the study to assess safety and effectiveness of the treatment in managing weight and associated health conditions.

Researchers are conducting a multi-center clinical study to assess artificial intelligence AI algorithms for measuring heart function and size using echocardiography. The study aims to compare AI measurements with those of physicians at different experience levels, evaluate the accuracy and stability of AI, and explore its use in complex heart conditions like cardiomyopathy, valve disease, and coronary heart disease. The goal is to improve diagnostic consistency and clinical workflows across medical centers. The study involves measuring cardiac chamber size and function in 1600 participants using AI, senior physicians, and intermediate physicians. All measurements are made with Mindray ultrasonic machines. AI and intermediate physician results are completed within one day after data collection, while senior physician results are completed within one month. The study will establish a standardized reference system for AI-assisted echocardiographic measurements and evaluate AIs performance in special cases. Participants will undergo echocardiographic scans with measurements of left and right ventricular size and function, Doppler ultrasound indicators, and valve annulus displacements. Researchers will analyze data to compare AI and physician measurements, assess measurement deviations, and evaluate AIs efficiency in reducing analysis time. The study will run until July 2026, with ongoing data collection and analysis across multiple centers, aiming to promote wider clinical application of AI technology for cardiovascular disease diagnosis.

This trial evaluates the safety and effectiveness of AHB-137 injection combined with other hepatitis B treatments in adults with HBeAg-negative chronic hepatitis B CHB who are already receiving nucleoside analogue therapy. It is a randomized, open-label, multicenter phase II study designed to find out if this combination can help control the virus better and improve patient outcomes. Participants are assigned to one of several groups receiving AHB-137 along with either pegylated interferon alpha-2b, hepatitis B vaccine, or both. The treatment durations vary, with some groups receiving AHB-137 for 16 or 24 weeks alone or in combination with pegylated interferon for up to 24 weeks. All treatments are administered by injection as part of the study protocol. During the study, participants will have regular assessments including measurements of hepatitis B surface antigen and viral DNA levels, liver enzyme tests, and antibody detection. Safety will be closely monitored through adverse event tracking and quality of life questionnaires. The primary outcome is the proportion of participants maintaining very low hepatitis B markers 24 weeks after stopping treatment, with follow-up assessments lasting up to 72 weeks after treatment completion.

Researchers are evaluating a new tuberculosis preventive treatment among adolescents and school staff who have been in close contact with active TB cases. This study compares a novel 1-month ultra-short regimen called 1H3P3 with the standard 3-month 3HR regimen, aiming to prevent latent TB infection from progressing to active tuberculosis. The trial is a phase 3, multi-center, open-label, cluster randomized controlled study conducted in school settings in China, with the goal of improving TB prevention strategies for adolescents. Participants are randomly assigned to receive either the 12-dose 1H3P3 regimen of isoniazid and rifapentine taken three times a week for one month, or the 3HR regimen of isoniazid and rifampicin taken once daily for three months. Close contacts of TB cases are screened using blood tests, chest X-rays, sputum testing, and symptom checks to rule out active TB before enrollment. The treatment period lasts either one or three months depending on the group, followed by two years of follow-up to monitor for TB development. During the study, participants will undergo regular assessments including monitoring for active tuberculosis through clinical and laboratory tests, adverse events, treatment adherence, and drug resistance if active TB occurs. The main measurement is the cumulative incidence of active TB over 24 months after treatment begins. Safety and treatment completion rates are tracked throughout. Participation involves screening, treatment administration, and periodic follow-up visits over two years to evaluate outcomes and overall TB prevention effectiveness.

Researchers are evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of LBL-024 in patients with advanced malignant tumors in a phase III clinical study. This study includes patients who have failed previous standard treatments, lack standard treatment options, or are not suitable for such treatments. The trial consists of two parts a phase IIIa dose escalation and pharmacokinetic expansion phase, and a phase IIb pivotal single-arm clinical study. Participants receive LBL-024 injections at the maximum tolerated dose every three weeks. The phase IIIa part focuses on dose escalation, safety, and preliminary efficacy, while the phase IIb part serves as a single-arm registry study to further assess the treatment. The study evaluates the drugs pharmacokinetic characteristics and immune response throughout treatment. During the study, participants are closely monitored for dose-limiting toxicities within three weeks of the first dose and maximum tolerated dose completion. Researchers assess objective response rate, adverse events, immunogenicity, disease control rate, and progression-free survival. Follow-up visits occur up to 30 days after treatment discontinuation or withdrawal. The total study duration extends until December 2026.

Researchers are comparing the safety and effectiveness of a new injection called GR2001 with Human Tetanus Immunoglobulin HTIG for preventing tetanus. This Phase III clinical trial focuses on adults who may have been exposed to tetanus through dirty or contaminated wounds. The study aims to see how well GR2001 works in raising protective antibody levels against tetanus. Participants will be randomly assigned to receive a single intramuscular injection of either GR2001 or HTIG in the gluteal muscle on the first day of the study. GR2001 is provided in a 5mg1ml vial with specific packaging materials, while HTIG is a licensed human plasma-derived immunoglobulin. Both treatments are given once, and the study is designed as a double-blind trial. During the trial, researchers will monitor the increase in anti-tetanus antibody levels up to 12 hours after injection and follow participants for up to 105 days to observe the occurrence of tetanus and assess safety. They will also evaluate how GR2001 behaves in the body, including its peak concentration and overall exposure. Participants will undergo assessments and safety monitoring throughout this period to gather comprehensive data on the treatment effects.

Researchers are evaluating oral icotrokinra as a treatment for adults and adolescents with moderately to severely active ulcerative colitis, a chronic inflammatory disease of the large intestine causing ulcers in the colon lining. The study aims to assess how well icotrokinra works, along with its safety and tolerability in this population. This is a Phase 3, randomized, double-blind, placebo-controlled trial with a parallel group design including both adults and adolescents. Adult participants will be randomly assigned to receive either icotrokinra or placebo daily by mouth during a 12-week induction phase. At Week 12, those showing clinical response will enter a maintenance phase where they will continue icotrokinra or placebo daily for 40 weeks. Adults who do not respond will also enter the maintenance phase and receive icotrokinra. Adolescents will receive open-label icotrokinra during induction and then continue on icotrokinra during maintenance regardless of response. After completing the 40-week maintenance phase, eligible participants may join a long-term extension study. Participants will be monitored regularly through clinical assessments at specified time points including Week 12 for induction and Week 40 for maintenance. Outcomes measured include rates of clinical remission, symptom improvement, endoscopic and histologic healing, and quality of life scores. Safety will be evaluated by tracking adverse and serious adverse events throughout the study. The total study duration may extend up to approximately 6 years, ending in 2032, allowing long-term evaluation of icotrokinra in ulcerative colitis management.