Huai Hua Shi

Researchers are conducting a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial to evaluate the efficacy and safety of TQH2929 injection in patients experiencing acute flare-ups of generalized pustular psoriasis (GPP). The study aims to provide evidence on how well TQH2929, a humanized monoclonal antibody, works in managing this severe skin condition. A total of 36 patients will participate in the trial. Participants will receive either TQH2929 injections or a placebo, with the placebo containing no active substance. The treatment is administered through injection, and all subjects will use either the study drug or placebo during the trial period. This setup allows researchers to compare outcomes between the two groups under controlled conditions. During the study, participants will be closely monitored through visits and procedures to assess treatment effects and safety. Researchers will measure outcomes such as the percentage of patients achieving a pustule score of zero after one week of treatment. Female participants of childbearing age must agree to use contraception during the study and for six months afterward. The trial will also include safety monitoring for infections, immune status, and other health factors over the course of participation.

Researchers are evaluating the safety and effectiveness of MC2-01 cream in treating Chinese adults aged 18 years and older with plaque psoriasis affecting the body (trunk and/or limbs). This phase 3, multi-center, randomized, investigator-blinded study compares MC2-01 cream to both calcipotriol and betamethasone dipropionate gel and a vehicle cream. The study includes screening, treatment, and safety follow-up periods to thoroughly assess the treatment's impact. Participants receive one of three treatments: MC2-01 cream (containing calcipotriene and betamethasone dipropionate), CAL/BDP gel (calcipotriol and betamethasone dipropionate gel), or a vehicle cream without active ingredients. Treatments are applied during the treatment period following the study protocol. The design allows comparison of MC2-01 cream’s efficacy and safety against the gel and vehicle. During the study, participants undergo evaluations including physician assessments using the Physician's Global Assessment (PGA) to measure treatment success on the body after 8 weeks. Researchers monitor safety and treatment response through scheduled visits covering screening, treatment, and follow-up phases. Participation involves completing visits as required by the protocol to ensure comprehensive data collection over the study duration.

Researchers are evaluating the safety and effectiveness of Meropenem and Pralurbactam compared to Ceftazidime and Avibactam Sodium in adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). This Phase 3 study is designed as a randomized, double-blind, active-controlled trial to demonstrate that Meropenem and Pralurbactam are not less effective than the comparator treatment. The study will include participants aged 18 to 80 years with signs and symptoms of HABP/VABP and new or worsening lung infiltrates. Participants are randomly assigned to receive either Meropenem and Pralurbactam or Ceftazidime-avibactam. Meropenem and Pralurbactam are given as a 3-gram infusion every 8 hours over 120 minutes, while Ceftazidime-avibactam is administered as a 2.5-gram infusion every 8 hours over 120 minutes. The study treatment period, along with screening and follow-up, spans approximately 32 days. Throughout the study, participants will be monitored for safety and treatment effects, including the proportion who die from any cause up to Day 14. Assessments will include clinical evaluations, imaging such as chest X-rays or CT scans, and monitoring of systemic and respiratory symptoms. Follow-up will continue after treatment to evaluate outcomes and safety over the entire study duration.

Researchers are evaluating the effectiveness of BDB-001 injection to induce remission in adults with active anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). This phase III, multicenter, randomized, double-blind, controlled study compares BDB-001 combined with cyclophosphamide followed by azathioprine or with rituximab. The trial focuses on patients diagnosed with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who require treatment with prednisone plus immunosuppressive therapy. Participants receive BDB-001 intravenously along with either cyclophosphamide followed by azathioprine or rituximab, both also given intravenously. Prednisone is part of the treatment regimen as well. The study assesses the safety and efficacy of this combination approach to induce disease remission. Treatment schedules follow standard dosing protocols for these medications. During the study, researchers monitor patients for remission using the Birmingham Vasculitis Activity Score (BVAS) at 24 weeks. Participants undergo regular assessments to evaluate disease activity and treatment response. Safety monitoring and follow-up visits are conducted throughout the trial duration to observe patient health and treatment effects.

Researchers are evaluating the effects of two treatments in people with H-type hypertension who have specific genetic types (MTHFR 677 CC or CT), elevated plasma homocysteine levels, and low serum folate. This large, phase 4 clinical trial involves 32,000 Chinese men and women aged 45 to 74 years. The study aims to compare the risk of first ischemic stroke over a five-year period between the two treatment groups. Participants will be divided into groups based on their MTHFR genotype and randomly assigned to receive either amlodipine tablets (5mg once daily) or amlodipine combined with folic acid tablets (5.8mg once daily). The study includes a screening period, a 2 to 4-week run-in phase to check tolerance and compliance to amlodipine, and a five-year randomized treatment phase. Additional blood pressure medications may be added if needed to maintain target blood pressure levels. During the study, participants will have visits every three months for drug distribution and monitoring. Researchers will collect blood samples, conduct clinical evaluations, and gather data on medication adherence and health outcomes. The primary outcome measured is the first occurrence of ischemic stroke by the end of five years. Safety and efficacy will be assessed, with two interim analyses planned at years three and four.

Researchers are studying the effects of three different treatment approaches on the risk of first ischemic stroke in Chinese men and women with hypertension and a specific genetic type called MTHFR 677 TT genotype. This large, phase 4 clinical trial will include 24,000 participants aged 45 to 74, and will compare the impact of amlodipine alone, amlodipine combined with folic acid, and amlodipine combined with folic acid plus 5-methyltetrahydrofolate (5-MTHF). The goal is to evaluate which treatment strategy might better prevent the first ischemic stroke over five years. The study has three main periods: screening, run-in, and randomized treatment. During screening, participants provide consent and undergo interviews, clinical evaluations, and lab tests to confirm eligibility. The run-in period lasts 2 to 4 weeks, where participants take amlodipine (5 mg once daily) to assess tolerance and compliance. After this, eligible participants are randomly assigned to one of three groups: amlodipine only, amlodipine plus folic acid, or amlodipine plus folic acid and 5-MTHF. Treatments are taken orally once daily for five years. Additional antihypertensive medications may be added as needed to keep blood pressure controlled. Participants will visit the research centers every three months for follow-up, medication distribution, and monitoring. Researchers will check blood pressure, collect biological samples, and assess compliance and safety throughout the five-year treatment. The study’s main outcome is the occurrence of a first ischemic stroke by the end of the fifth year. Two interim analyses are planned at years three and four to evaluate ongoing results while maintaining study integrity.

Researchers are evaluating the safety and effectiveness of giving tirofiban early to patients who have received tenecteplase for acute ischemic stroke. This phase 3 study addresses the problem of reocclusion that happens in 14-34% of patients after thrombolysis, likely due to platelet activation. The goal is to see if adding tirofiban soon after tenecteplase can reduce this risk and improve patient outcomes. Participants will be randomly assigned to receive either a continuous intravenous infusion of tirofiban or a placebo. The infusion starts at 0.3 micrograms per kilogram per minute for 30 minutes, followed by 0.075 micrograms per kilogram per minute for 47.5 hours, beginning within 4 to 24 hours after tenecteplase treatment. Aspirin and/or clopidogrel placebos are given orally 24 hours after tenecteplase, with actual antiplatelet therapy starting at 44 hours and continuing until 90 days after randomization. During the study, participants are monitored for neurological function changes and safety. The main outcome measured is excellent functional recovery 90 days after randomization. The study includes neurological assessments, imaging tests, and laboratory evaluations. Participants are followed for 90 days to observe treatment effects and any adverse events.

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.