[Translation] Phase I clinical study to evaluate the safety, biodistribution, radiation dose and pharmacokinetics of 68Ga-HX01 injection for PET imaging
Ia期: 主要目的:评估中国健康成人受试者接受单次静脉给予68Ga-HX01注射液后的安全性。 次要目的:探索中国健康成人受试者接受单次静脉给予68Ga-HX01注射液后的生物分布(PET显像)、人体的辐射剂量和药代动力学特征。 Ib期:
主要目的:评估恶性实体瘤患者接受单次静脉给予68Ga-HX01注射液后的安全性。
次要目的:探索恶性实体瘤患者接受单次静脉给予68Ga-HX01注射液后的生物分布(PET显像)。
探索性目的:探索在恶性实体瘤患者中单次静脉给予68Ga-HX01注射液后的肿瘤显像特点。
[Translation] Phase Ia: Primary objective: To evaluate the safety of a single intravenous injection of 68Ga-HX01 in healthy Chinese adult subjects. Secondary objective: To explore the biodistribution (PET imaging), radiation dose and pharmacokinetic characteristics of a single intravenous injection of 68Ga-HX01 in healthy Chinese adult subjects. Phase Ib:
Primary objective: To evaluate the safety of a single intravenous injection of 68Ga-HX01 in patients with malignant solid tumors.
Secondary objective: To explore the biodistribution (PET imaging) of a single intravenous injection of 68Ga-HX01 in patients with malignant solid tumors.
Exploratory objective: To explore the tumor imaging characteristics of a single intravenous injection of 68Ga-HX01 in patients with malignant solid tumors.