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Clinical Trials associated with GC304 Adeno-Associated Virus评价GC304腺相关病毒注射液治疗伴有急性胰腺炎病史的原发性高甘油三酯血症患者的安全性和耐受性的I期临床试验
[Translation] A phase I clinical trial to evaluate the safety and tolerability of GC304 adeno-associated virus injection in the treatment of patients with primary hypertriglyceridemia with a history of acute pancreatitis
主要目的:
评价 GC304 腺相关病毒注射液治疗伴有急性胰腺炎病史的原发性高甘油三酯 血症患者用药后 12 周的安全性和耐受性
次要目的:
1、评价GC304腺相关病毒注射液用药后12周内甘油三酯水平的变化情况;
2、评价GC304腺相关病毒注射液用药后12周内免疫原性反应;
3、评价GC304腺相关病毒注射液用药后12周内药代动力学(全血GC304载体基因组
拷贝数)情况;
4、评价GC304腺相关病毒注射液用药后12周内病毒载体脱落情况。
[Translation] Main purpose:
To evaluate the safety and tolerability of GC304 adeno-associated virus injection in the treatment of primary hypertriglyceridemia patients with a history of acute pancreatitis after 12 weeks of medication
Secondary objectives:
1. To evaluate the changes in triglyceride levels within 12 weeks after the administration of GC304 adeno-associated virus injection;
2. To evaluate the immunogenicity response within 12 weeks after the administration of GC304 adeno-associated virus injection;
3. To evaluate the pharmacokinetics (whole blood GC304 vector genome
copy number) of GC304 adeno-associated virus injection within 12 weeks after the administration of GC304 adeno-associated virus injection;
4. To evaluate the shedding of viral vector within 12 weeks after the administration of GC304 adeno-associated virus injection.
100 Clinical Results associated with GC304 Adeno-Associated Virus
100 Translational Medicine associated with GC304 Adeno-Associated Virus
100 Patents (Medical) associated with GC304 Adeno-Associated Virus
100 Deals associated with GC304 Adeno-Associated Virus