Jiaxing

Researchers are evaluating the safety and effectiveness of two antibiotic treatments, omadacycline and moxifloxacin, in Chinese adults with community-acquired bacterial pneumonia (CABP). This Phase 3b study is designed as a bridging trial to confirm whether omadacycline works as well as moxifloxacin in this specific population, building on results from a global CABP trial. Participants will receive either omadacycline or moxifloxacin through intravenous or oral routes. The treatments are given as a course, with details on dosing schedules not specified. The study compares these two drugs directly to assess their clinical efficacy and safety in treating CABP. During the study, participants will be monitored and evaluated for their clinical response at 18 months after therapy. Researchers will assess symptoms, vital signs, and overall health related to pneumonia to determine treatment success. Safety and efficacy data collected throughout the study will help understand how well each drug performs in this patient group.

Researchers are evaluating the safety and effectiveness of Ademetionine in patients with obstructive hypertrophic cardiomyopathy (oHCM). This multicenter, double-blind, randomized controlled Phase 2 trial aims to compare Ademetionine with a placebo to understand its impact on exercise capacity, heart failure symptoms, heart structure and function, and quality of life in people with oHCM. Participants will be randomly assigned to receive either Ademetionine 1,4-Butanedisulfonate, an oral drug marketed as Ximeixin in China, or an identical placebo tablet. The study treatment will last 16 weeks with follow-up visits every 4 weeks during this period. After 16 weeks, researchers will assess the effects of the treatment on various health outcomes and monitor safety and tolerability. During the study, participants will undergo cardiopulmonary exercise testing (CPET) to measure changes in peak oxygen consumption from the start to the end of treatment. Additional assessments will include evaluations of heart function, symptoms, and quality of life. Participants must comply with scheduled visits and medication requirements throughout the trial to support accurate monitoring and data collection.

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 investigating the use of neoadjuvant chemotherapy combined with Toripalimab in female patients aged 18 to 70 years with triple-negative breast cancer (TNBC). This phase II, prospective, single-arm, multi-center clinical trial aims to evaluate the pathologic complete response (PCR) rate to this treatment and monitor the types and incidences of any adverse events. Secondary objectives include observing disease-free survival (DFS), progression-free survival (PFS), and objective response rate (ORR). The treatment involves two phases of neoadjuvant chemotherapy combined with Toripalimab. The first phase includes intravenous administration of Epirubicin, Cyclophosphamide, and Toripalimab every three weeks for six weeks. The second phase involves intravenous Albumin-bound Paclitaxel with Toripalimab on the same schedule for another six weeks. After completing four cycles of neoadjuvant chemotherapy, patients undergo breast cancer radical surgery. Post-surgery, if the pathology shows a complete response, patients continue immunotherapy with Toripalimab every three weeks for one year. If not, they receive postoperative adjuvant chemotherapy combined with Toripalimab. Gene testing on biopsy tissue and blood samples for ctDNA testing are performed before and after treatment. Participants will be closely monitored throughout the study, including assessments of adverse events and treatment responses. Researchers will collect tissue and blood samples to analyze genetic markers and circulating tumor DNA. The primary outcome measure is the pathologic complete response two years after treatment. Safety, disease progression, and survival outcomes will also be evaluated. The study requires participants to comply with follow-up and treatment schedules over the course of the trial.

Researchers are evaluating the safety and immune response of a freeze-dried herpes zoster virus mRNA vaccine in adults aged 40 years and older. The study includes two parts: Part A focuses on safety and early immune response in healthy people aged 40 and above, while Part B aims to find the best dose and schedule for those aged 50 and older to support future research. This randomized, double-blind, controlled trial involves detailed safety monitoring and immune system evaluations. Participants receive two doses of the study vaccine, which may be a low or high dose lyophilized herpes zoster mRNA vaccine, an active-controlled vaccine (herpes zoster live attenuated vaccine or Shingrix®), or a saline placebo. In Part A, age and dose groups are enrolled sequentially, and in Part B, participants are randomly assigned to different vaccine doses or schedules. Immune responses in the blood and cells are measured, and immune protection over time is also assessed. During the study, participants undergo safety observations throughout and have their immune responses tested at various times, including 30 days after vaccination. Researchers monitor for any side effects within 30 days after each dose and measure antibody levels to the virus. The study requires participants to follow visit schedules, vaccination, and sample collection procedures, with ongoing accessibility for the trial duration.

Researchers are investigating the safety and effectiveness of Inpegsomatropin injection compared to recombinant human growth hormone (rhGH) in children with idiopathic short stature (ISS). This Phase III, multicenter, randomized, open-label clinical trial aims to enroll 300 children with ISS. Participants will be divided by gender and age and assigned to either the experimental treatment or the active control group to assess growth outcomes. The study involves two treatment groups: one receiving Inpegsomatropin injection at a dose of 280 mcg/kg once weekly by subcutaneous injection for 52 weeks, and the other receiving recombinant human growth hormone at 350 mcg/kg per week, divided into daily doses of 50 mcg/kg, also by subcutaneous injection for 52 weeks. The trial includes a screening period lasting up to 12 weeks before treatment, followed by the 52-week treatment phase, and a post-treatment follow-up period of 5 weeks to monitor effects and safety. Participants will undergo evaluations including growth velocity measurement at week 52, along with safety assessments throughout the study. The trial monitors height changes, bone age, hormone levels, and overall health. Guardians must provide informed consent, and children aged 8 years or older must also assent. The total participation time ranges from screening through follow-up, ensuring careful observation of treatment impact and participant well-being.