Tong Hua Shi

Researchers are evaluating TQB2102, a new antibody-drug conjugate designed to target tumor cells in patients with recurrent or metastatic advanced gynecological tumors. This Phase 2 study focuses on assessing the safety and effectiveness of TQB2102, which combines a humanized antibody against HER2 with a powerful drug payload to kill cancer cells more specifically and potently than traditional treatments. The study includes patients who have not responded successfully to previous platinum-based chemotherapy. Participants will receive TQB2102 injections, which is a HER2 dual-antibody-drug conjugate. The treatment is given to women with measurable lesions confirmed by RECIST 1.1 criteria, and who have varying levels of HER2 expression in their tumor tissue. Women of childbearing potential must have a negative pregnancy test before starting and agree to use highly effective contraception throughout the study. The treatment period and dosing schedules are designed to monitor the drug's impact carefully. Throughout the study, participants will be closely monitored for overall response rate up to 12 months. Assessments include regular evaluations of tumor response, safety checks, and compliance with treatment. The study excludes patients with certain health conditions, recent surgeries, or other treatments that might interfere. The total duration and detailed follow-up procedures ensure thorough observation of TQB2102's effects and participant safety.

This research aims to evaluate the effectiveness and safety of early treatment with BXOS110 injection in patients who have experienced an acute ischaemic stroke within 3 hours of symptom onset. The trial is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study designed to clarify how well BXOS110 reduces overall disability after stroke compared to placebo. Participants include adults diagnosed with acute ischaemic stroke meeting specific neurological criteria. Participants are randomly assigned in equal numbers to receive either an intravenous infusion of BXOS110 at a dose of 3.0 mg/kg (up to a maximum of 300 mg) or a placebo infusion of the same volume and dose. The study consists of a screening and baseline period where consent and eligibility are confirmed within 3 hours of stroke onset, followed by a treatment phase where the assigned infusion is administered. Afterwards, participants enter a follow-up period with evaluations at Day 2, Day 3, Day 10 or discharge (whichever comes first), Day 30, and Day 90 after treatment. Throughout the study, participants will undergo assessments to monitor efficacy and safety, including the primary outcome of the proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at Day 90, indicating reduced disability. Neurological status, adverse events, and overall health will be evaluated during scheduled visits. The total duration of participation spans from initial screening through the 90-day follow-up, with close monitoring to understand the impact of BXOS110 on stroke recovery.

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 how well oral icotrokinra works, its safety, and how well patients tolerate it in adults and adolescents with moderately to severely active ulcerative colitis, a chronic condition where the colon lining becomes inflamed and develops ulcers. This is a Phase 3 study aimed at finding effective treatments for this condition using a rigorous comparison. Participants will receive either icotrokinra tablets or placebo tablets taken by mouth. The study includes an induction phase and a maintenance phase, with adults participating in a randomized, double-blind, placebo-controlled design, while adolescents join an open-label maintenance study. Throughout the study, researchers will monitor clinical remission rates at 12 weeks during induction and at 40 weeks during maintenance. Participants will undergo assessments including endoscopic evaluations and pregnancy tests for females of childbearing potential. Safety and tolerability will be closely observed, with the total study duration covering both induction and maintenance periods.

This research aims to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study focuses on participants who meet specific IBS-D criteria related to bowel movement patterns and abdominal pain. It is a Phase 2, randomized, double-blind, placebo-controlled trial lasting approximately 35 weeks. Participants will receive either brenipatide or a placebo, both administered under the skin through subcutaneous injection. The treatments are compared to assess their impact on IBS-D symptoms. The study involves careful monitoring of patients' responses to the medication over the treatment period, with no changes in diet allowed in the four weeks before screening. During the study, participants will track their symptoms daily using an electronic diary, including abdominal pain and stool consistency. Researchers will measure the percentage of days participants have a positive composite response between weeks 9 and 16. Safety and side effects will be monitored throughout the study, ensuring participants are closely observed during the full duration of about 35 weeks.

Researchers are evaluating the safety and effectiveness of lebrikizumab in people aged 12 years and older who have chronic rhinosinusitis with nasal polyps and are being treated with intranasal corticosteroids. This Phase 3 study is designed to better understand how lebrikizumab works alongside standard nasal spray treatments over a period of about 18 months. Participants will receive either lebrikizumab or a placebo by subcutaneous injection, while continuing their regular intranasal corticosteroid spray treatment. The study is randomized, double-blind, and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo. The study measures changes from baseline in nasal congestion severity and nasal polyp size using participant reports and endoscopic scoring at the start and after 24 weeks. During the study, participants will undergo evaluations including nasal examinations and symptom assessments at specified times. Researchers will monitor nasal polyp scores and nasal congestion severity to assess treatment impact. Safety and side effects will also be closely observed throughout the study. The total duration of participation is approximately 18 months, allowing careful tracking of treatment outcomes and safety over time.

Researchers are investigating the safety, tolerability, pharmacokinetics, and appropriate dosing of oral ABSK-011 in patients with advanced solid tumors in this open-label Phase 1 study. The study includes both an escalation phase to identify the maximum tolerated dose and a subsequent expansion phase to further assess safety and tolerability in patients with advanced liver cancer (HCC) who overexpress FGF19. Preliminary antitumor activity of ABSK-011 will also be evaluated. During the escalation phase, oral ABSK-011 is administered starting at a once-daily dose, with dose adjustments and different dosing frequencies such as twice daily explored based on safety and pharmacokinetic data. A food effect cohort might be included. In the expansion phase, patients receive the recommended dose determined from the escalation part. Treatment continues through cycles of 28 days each. Participants undergo regular monitoring including physical exams, ECGs, echocardiograms, vital signs, and performance status assessments throughout about six months of study treatment. Safety evaluations include tracking adverse events, dose-limiting toxicities, dose reductions, and discontinuations. Patients provide tissue samples for FGF19 testing, and tumor response is measured. The study also monitors viral levels in patients with hepatitis B virus infection. Participants are expected to comply with study visits and procedures for the duration of the trial.

Researchers are evaluating the efficacy, safety, and pharmacokinetics/pharmacodynamics of TQH3906 capsules in adults with moderate-to-severe active ulcerative colitis or Crohn's disease. This phase Ib study follows dose escalation in the 24mg twice daily group from Phase I and uses a randomized, double-blind, placebo-controlled design. It aims to include 105 subjects, half of whom have failed conventional therapy and the other half failed biologic therapy, to better understand treatment effects in these populations. Participants will be randomly assigned in equal numbers to one of three groups: a placebo group, a 32mg dose group, or a 24mg twice daily dose group of TQH3906 capsules. The exact dose levels will be adjusted based on prior medication experience from Phase I. The study includes up to a 4-week screening period, a 12-week treatment period, and a 4-week follow-up period after treatment ends. During the trial, participants will undergo assessments to monitor safety and effectiveness, including evaluation of adverse events from baseline to week 16 and measuring clinical remission rates at week 8 using the Mayo score for ulcerative colitis and other assessments for Crohn's disease. Researchers will also observe pharmacokinetics and pharmacodynamics throughout the study. The total time commitment for participants is approximately 20 weeks combining screening, treatment, and follow-up.

Researchers are evaluating the safety and effectiveness of QD202 injection in patients who have experienced an acute ischemic stroke and are undergoing thrombolysis, but not endovascular thrombectomy. This is a Phase II randomized, double-blind, placebo-controlled study involving up to 120 male and female participants aged 18 to 85 years. The trial aims to measure safety and tolerance over an average of 90 days following treatment. Participants will receive either QD202, a 19 amino acid peptide designed to cross the blood-brain barrier, or a matching placebo. The assigned treatment is given as a 60-minute intravenous infusion after completing the thrombolysis procedure, during the first five days of the study. Follow-up assessments take place on Day 7 or at discharge, Day 30, and at the study's end on Day 90. Throughout the study, participants will undergo neurological evaluations and safety monitoring, including clinical assessments related to stroke recovery. Researchers will collect data on treatment safety and how well patients tolerate the infusion. The total involvement period for each participant is approximately 90 days, allowing for careful observation and measurement of outcomes after the intervention.

Researchers are evaluating the effectiveness and safety of the KPCXM18 injection at different doses for treating acute ischemic stroke in this multicenter, randomized, double-blind, placebo-controlled phase 2 trial. The study aims to determine how well the injection works and to explore its safety profile, including population pharmacokinetic characteristics, to support future phase 3 studies. Participants will be randomly assigned to one of three groups: a low-dose KPCXM18 injection group receiving 60 mg intravenously twice daily, a high-dose group receiving 100 mg intravenously twice daily, or a placebo group receiving a matching intravenous infusion. Treatments will be given every 122 hours continuously for 122 days to assess dose-related effects. During the study, participants will undergo assessments including the Modified Rankin Scale at day 90 to measure recovery. Researchers will monitor safety and efficacy throughout the treatment and follow-up periods. The total number of participants is planned to be 300, with 100 in each group, all aged between 18 and 80 years old who have experienced acute ischemic stroke within 12 hours of symptom onset.