[Translation] Study on the pharmacokinetics, biodistribution, radiation dose and safety of gallium [68Ga]-NYM032 injection in healthy subjects and prostate cancer patients
Ⅰa期
主要目的:
评估68Ga-NYM032注射液在健康受试者体内的安全性和辐射安全性。 次要目的:
1、评价不同剂量68Ga-NYM032注射液在健康受试者体内的药代动力学;
2、评价不同剂量68Ga-NYM032注射液在健康受试者体内的生物分布;
3、评价不同剂量68Ga-NYM032注射液在健康受试者体内的图像质量。
Ⅰb/Ⅱa期
主要目的:
评估68Ga-NYM032注射液在前列腺癌患者体内的安全性和辐射安全性。 次要目的:
1、评价68Ga-NYM032注射液在前列腺癌患者体内的药代动力学;
2、评价68Ga-NYM032注射液在前列腺癌患者体内的生物分布;
3、评价68Ga-NYM032注射液在前列腺癌患者体内的图像质量;
4、评价68Ga-NYM032注射液在前列腺癌患者体内的诊断效能;
5、评价不同阅片间和同一阅片者内68Ga-NYM032注射液在前列腺癌患者体内的诊断一致性。
[Translation] Phase Ia
Main purpose:
To evaluate the safety and radiation safety of 68Ga-NYM032 injection in healthy subjects. Secondary purposes:
1. To evaluate the pharmacokinetics of different doses of 68Ga-NYM032 injection in healthy subjects;
2. To evaluate the biodistribution of different doses of 68Ga-NYM032 injection in healthy subjects;
3. To evaluate the image quality of different doses of 68Ga-NYM032 injection in healthy subjects.
Phase Ib/IIa
Main purpose:
To evaluate the safety and radiation safety of 68Ga-NYM032 injection in patients with prostate cancer. Secondary objectives:
1. Evaluate the pharmacokinetics of 68Ga-NYM032 injection in patients with prostate cancer;
2. Evaluate the biodistribution of 68Ga-NYM032 injection in patients with prostate cancer;
3. Evaluate the image quality of 68Ga-NYM032 injection in patients with prostate cancer;
4. Evaluate the diagnostic efficacy of 68Ga-NYM032 injection in patients with prostate cancer;
5. Evaluate the diagnostic consistency of 68Ga-NYM032 injection in patients with prostate cancer between different readers and within the same reader.