Jinhua

This will be a confirmatory, prospective, open-label, single-arm, multi-centre study in a Chinese patient population. The study is designed to evaluate the safety, tolerability, sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect Clear Cell Renal Cell Carcinoma (ccRCC). The multi-centre study will be conducted in mainland China in adult patients with Indeterminate Renal Masses (IRM), who are scheduled for partial or total nephrectomy as part of their standard of care. Approximately 82 evaluable adult patients will be recruited from approximately 8 renal cancer care specialist centres with access to state-of-the-art PET/CT imaging in mainland China. The number of enrolled participants may be increased to ensure sufficient confidence in measuring sensitivity and specificity of 89Zr-TLX250 PET/CT imaging. The study involves a single administration of 37 MBq (±10%) of 89Zr-TLX250, containing a mass dose of 10 mg of girentuximab, in mainland Chinese participants (ZIRCON-CP). This is consistent with the confirmatory, prospective, multinational clinical trial ZIRCON (ClinicalTrials.gov ID: NCT03849118). This study consists of seven visits. Imaging will then be conducted 5±2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory. On Day 5±2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator. Image data analyses will be performed by a central imaging vendor. For participants who were nephrectomised within 28 days post administration, the final study visit will be conducted on Day 42 (±7 days). For participants with nephrectomy between 28 and 90 days post administration, the final study visit will be performed 35 days (±7 days) after surgery. Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or Magnetic Resonance Imaging \[MRI\]), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth. The duration of this study is expected to be about 12 months, with a follow-up of 4 months. The study duration for a single participant will be approximately between 4 - 6 months. No interim analysis is planned for this study.

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 during Dose Escalation phase and preliminary antitumor activity in patients with NSCLC with concurrent KRAS G12C mutant and STK11 mutant and KEAP wild type either treatment naïve or at least one line prior therapy for advance disease during the expansion phase..

Researchers are evaluating the safety, tolerability, pharmacokinetics, and early effectiveness of XS-04 tablets in adults with relapsed or refractory hematologic cancers, including B-cell lymphoma, acute myeloid leukemia, and myelodysplastic syndrome. This phase 1 trial aims to find the highest dose patients can tolerate and the recommended dose for future studies while also exploring how the drug is processed in the body and its relationship with biomarkers and food intake. Participants receive XS-04 tablets taken orally twice a day in continuous 28-day treatment cycles. The study includes a dose escalation phase for patients with mature B-cell malignancies who have exhausted other treatments, and a dose expansion phase for patients with specific types of B-cell lymphoma and myeloid tumors. The study evaluates the drug's effects over up to 24 months, monitoring for dose-limiting toxicities and determining the maximum tolerated dose or recommended phase 2 dose. Participants will undergo regular assessments including physical exams, laboratory tests, bone marrow biopsies, and imaging to measure tumor lesions. Researchers will monitor side effects, drug levels, and biological markers throughout the study. Safety will be checked at the end of each treatment cycle, and participants are expected to comply with study procedures and follow-up visits to help evaluate XS-04's impact and tolerability.

Hydronidone capsules are small molecule compounds that have shown safety and effectiveness in treating liver fibrosis in chronic hepatitis B during earlier Phase I and II trials. The current research focuses on understanding how Hydronidone behaves in the body and its safety in patients with varying levels of kidney function, including those with renal insufficiency and healthy subjects. This is a Phase 1 study aimed at providing guidance for clinical use in patients with kidney problems. Participants receive a single oral dose of 90 mg Hydronidone capsules on an empty stomach on the first day. The study involves groups with different kidney function levels to compare how the drug and its metabolites are processed. This includes patients with mild, moderate, or severe renal dysfunction as well as healthy volunteers. The study measures drug levels in plasma and urine over 48 hours after administration to understand the pharmacokinetics of Hydronidone and its metabolites. During the study, participants will be monitored closely with blood and urine tests to assess drug concentration and safety. Researchers will measure various pharmacokinetic parameters such as plasma drug concentration, metabolite levels, and timing of peak drug presence. Participants are expected to comply with lifestyle restrictions such as avoiding smoking, alcohol, caffeine, and certain foods before and during the study. The total participation age range is from 18 to 70 years, and safety is carefully observed throughout the study period.

Researchers are studying the effectiveness and safety of Tegileridine Fumarate Injection to maintain prolonged abirritation (48 to 72 hours) during mechanical ventilation in patients in the intensive care unit (ICU). This Phase II trial compares different doses of Tegileridine Fumarate Injection with Remifentanil Hydrochloride for Injection as a positive comparator. The goal is to assess how well these treatments maintain the target abirritation level during mechanical ventilation in ICU patients aged 18 to 85 years. Participants receive either a low or high dose of Tegileridine Fumarate Injection or Remifentanil Hydrochloride for Injection while on mechanical ventilation. The study monitors the drug administration over a period designed to achieve prolonged abirritation. The treatments are given during the period of mechanical ventilation, which must have lasted at least 48 hours, following initial intubation and ventilation for 24 hours or more. During the study, patients will be closely monitored for the rate of abirritation success, defined as maintaining the target abirritation for at least 70% of the drug administration time within three days after starting the study drug. Assessments include clinical evaluations and safety monitoring. The study also tracks side effects and other safety outcomes over the course of treatment, with a focus on ICU patients requiring prolonged mechanical ventilation.

This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).

Researchers are conducting a multicenter observational study to better understand the treatment outcomes for patients diagnosed with psoriasis by dermatologists in clinic settings across China. Psoriasis is a chronic, recurrent inflammatory disease influenced by genetic and environmental factors, presenting as erythematosquamous lesions and potentially affecting multiple organs. The study aims to compare the effectiveness of various treatments chosen by patients, including phototherapy, traditional systemic therapies, and biologics, in real-world clinical practice. This non-interventional study allows patients to select their preferred treatment without restrictions. Data is collected primarily through a phone application called "Psoriasis New World," enabling continuous monitoring of patient progress. The study evaluates multiple outcomes such as the Psoriasis Area and Severity Index (PASI), which measures skin lesion severity and body area involvement, along with the Physician Global Assessment, Investigator Global Assessment, Body Surface Area affected, and Dermatology Life Quality Index. Patient safety is monitored throughout, including the recording of any adverse events and laboratory tests such as liver function. Participants will be followed over six months to measure the percentage achieving complete clearance of psoriasis symptoms (PASI 100). Regular assessments of disease severity and quality of life changes will be conducted remotely via the app. Continuous safety monitoring ensures any side effects or complications are documented. This approach provides comprehensive real-world evidence on how different psoriasis treatments perform in routine clinical care.

Researchers are evaluating the efficacy, safety, and immune response of a bivalent enterovirus-inactivated vaccine (Vero cell) in healthy children aged 6 to 71 months. This Phase III, multicenter, randomized, double-blind, controlled trial compares this investigational vaccine to an EV71-inactivated vaccine (Vero cell) to prevent Hand, Foot, and Mouth Disease (HFMD) caused by CA16 infection and Herpangina (HA). The study aims to determine the primary vaccine efficacy against HFMD from CA16 and whether the neutralizing antibody levels against EV71 in the trial group are not inferior to those in the control group after two vaccine doses. Participants are randomly assigned in equal numbers to receive either two doses of the bivalent enterovirus vaccine or the control EV71 vaccine, with a one-month interval between doses. After the first dose, participants enter a monitoring period that lasts through two consecutive epidemic seasons. Subgroups of participants are selected for detailed safety monitoring, immune response testing, and analysis of injection site effects. Blood samples are collected at multiple time points to measure antibody levels and immune cell activity. Adverse events are closely tracked from vaccination through several months afterward. During the study, researchers actively follow participants for signs of enterovirus infection. If symptoms appear, throat or rectal swabs are collected for laboratory testing to confirm infection types. Safety is monitored by recording all adverse events shortly after vaccination and serious adverse events for six months after the second dose. The trial includes a detailed schedule of visits, sample collections, and vaccinations to evaluate vaccine protection, immune response, and safety over a one-year period. Genetic analysis of virus samples helps further understand infection subtypes.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of FS-8002 alone and in combination therapy for patients with advanced solid tumors. This open, single-arm Phase I clinical trial focuses on patients who have not responded to or cannot tolerate standard treatments. The study aims to understand how the drug behaves in the body and its potential benefits in this patient group. Participants will receive FS-8002 injections every three weeks. In addition, they may receive Toripalimab injections and chemotherapy chosen by the investigator, also administered every three weeks. Treatment continues until disease progression, unacceptable side effects, death, loss of follow-up, voluntary withdrawal, or study end. This approach allows researchers to assess the combined effects of these therapies over time. Throughout the study, participants will be closely monitored for safety and side effects for up to two years. Key outcomes include the maximum tolerated dose, recommended dose, dose-limiting toxicities, adverse events, and serious adverse events. Patients will undergo regular evaluations to track the disease and treatment effects. The total participation time is approximately two years, ensuring thorough assessment of safety and preliminary efficacy.