[Translation] A single-center, open-label, non-randomized, single-arm Phase I clinical study to evaluate the safety, biodistribution, radiation dose and pharmacokinetics of the novel 18F-labeled myocardial perfusion PET imaging agent XTR004 injection in healthy adults
主要目的:评估中国健康成年人接受单次弹丸式静脉给予 XTR004 注射液后人体的安全性。 次要目的:探讨中国健康成年人接受 XTR004 注射液单次弹丸式静脉给药后的(PET 显像)生物分布、对人体的辐射剂量、在人体内的药代动力学特征。
[Translation] Primary objective: To evaluate the safety of XTR004 injection after a single intravenous bolus in healthy Chinese adults. Secondary objective: To explore the biodistribution (PET imaging), radiation dose to humans, and pharmacokinetic characteristics of XTR004 injection after a single intravenous bolus in healthy Chinese adults.