[Translation] Phase I/Ila clinical trial to evaluate the safety, radiation dosimetry and pharmacokinetics of fluoro[18F]pyramide injection in healthy Chinese adult subjects and the diagnostic efficacy of PET/CT in melanoma patients
I期 (1)评价氟[18F]吡酰胺注射液在中国健康受试者中的安全性和耐受性。
(2)评价氟[18F]吡酰胺注射液在中国健康受试者中的生物分布和辐射剂量学
特征。(3)评价氟[18F]吡酰胺注射液在中国健康受试者中的药代动力学特征。
Ila 期
(1)评价在不同剂量和成像时间下,氟[18F]吡酰胺注射液PET/CT 在黑色素瘤
患者中的诊断效能,确定最佳成像条件。
(2)评价氟[18F]吡酰胺注射液在黑色素瘤患者中的安全性。
[Translation] Phase I (1) Evaluate the safety and tolerability of fluoro[18F]pyramide injection in healthy Chinese subjects.
(2) Evaluate the biodistribution and radiation dosimetry characteristics of fluoro[18F]pyramide injection in healthy Chinese subjects.
(3) Evaluate the pharmacokinetic characteristics of fluoro[18F]pyramide injection in healthy Chinese subjects.
Phase Ila
(1) Evaluate the diagnostic efficacy of fluoro[18F]pyramide injection PET/CT in melanoma patients at different doses and imaging times, and determine the optimal imaging conditions.
(2) Evaluate the safety of fluoro[18F]pyramide injection in melanoma patients.