Le Shan Shi

Researchers are evaluating BLU-5937, an oral drug, in adults with refractory chronic cough, including unexplained chronic cough, in a randomized, double-blind, placebo-controlled Phase 3 study. The main goal is to assess how BLU-5937 affects 24-hour cough frequency over 24 weeks. This study also monitors safety by tracking adverse events and changes in various health parameters during the treatment period. Participants are randomly assigned to one of three groups BLU-5937 25 mg twice daily, BLU-5937 50 mg twice daily, or a matching placebo taken twice daily. The treatment lasts for 24 weeks, and participants receive their assigned oral medication regularly throughout this time. The study uses a parallel-arm design and includes an extension in China. During the study, participants undergo assessments including cough frequency measurement, vital signs, blood tests for hormones and chemistry, hematology, and ECGs at baseline and Week 24. Researchers also evaluate cough severity and quality of life using questionnaires. Safety is closely monitored by recording adverse events, treatment discontinuations, and laboratory changes. The total participation duration is 24 weeks, with follow-up assessments at specified intervals.

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.

This research aims to evaluate the safety and effectiveness of TQA2225AP025, a recombinant human FGF21-Fc fusion protein, in adults with Non-Alcoholic Steatohepatitis NASH. It is a randomized, double-blind, placebo-controlled Phase II study designed to assess how well two different doses of this treatment work in managing NASH, a liver condition characterized by fat buildup and inflammation. Participants will receive either 25mg or 50mg of TQA2225AP025 or a matching placebo, given by weekly subcutaneous injections for 48 weeks. The study includes two experimental groups receiving the different doses, and all treatments are administered under blinded conditions to assess the treatment effects accurately. During the study, participants will undergo liver biopsies at the start and after 48 weeks to measure changes in liver condition using the NASH CRN scoring system. Safety will be closely monitored by tracking any adverse events throughout the treatment period. The study is expected to provide detailed information on both the treatment impact on liver health and its safety profile over nearly a year of participation.

Researchers are evaluating the safety and effectiveness of low-dose tenecteplase in elderly patients aged 70 and older who have experienced an acute ischemic stroke. This multicenter, randomized controlled trial focuses on treatment within 4.5 hours of stroke onset to assess how this therapy may improve neurological outcomes compared to a standard dose. Participants are randomly assigned to receive either a low dose 0.175 mgkg, up to 17.5 mg or a standard dose 0.25 mgkg, up to 25 mg of tenecteplase given intravenously. The study is designed as a parallel-group trial comparing these two dosing regimens to understand which may be more beneficial and safe for elderly stroke patients. Participants will be monitored for recovery and safety through neurological assessments using scales such as the Modified Rankin Scale and the National Institutes of Health Stroke Scale up to 90 days after treatment. Outcomes like neurological improvement, functional independence, quality of life, and any bleeding events will be closely measured. The trial will continue until December 2028, with follow-up visits planned to evaluate participants progress and overall health.

This research aims to evaluate the potential for patients with severe asthma treated with Tezepelumab to safely reduce their background maintenance asthma medications while keeping their asthma symptoms under control. It is a Phase 3b, single-arm, multi-center study conducted in China involving about 400 patients aged 12 to 80 years who have severe asthma and are on medium to high doses of ICSLABA therapy with or without additional controllers. The study focuses on Chinese patients maintaining asthma control after starting Tezepelumab treatment. Participants will receive Tezepelumab treatment while maintaining their current asthma medications initially. The study will observe the potential to step down or reduce these background therapies over time. The treatment period lasts up to 52 weeks, during which researchers will monitor how well patients maintain asthma control while reducing their standard controller regimen. This single-arm study does not include a comparator group. Participants will be involved for up to 52 weeks, during which their lung function, asthma symptom control, exacerbation rates, and quality of life will be assessed regularly. Various questionnaires, pulmonary function tests, symptom diaries, and biomarker evaluations will be conducted from the start of treatment through week 52. Safety and efficacy measures will be monitored throughout the study to assess the impact of reducing background asthma medications while on Tezepelumab.