a clinical study of 68ga-hx01 injection for pet imaging

Conditions: Healthy; Malignancy

Summary: this is a single-center, open phase i clinical study, consisting of two parts: a phase ia study in healthy adult subjects and a phase ib study in patients with malignant solid tumors.

phase ia design: the phase ia study is designed to evaluate the safety, biodistribution (pet imaging), radiation dose, and pharmacokinetics of 68ga-hx01 injection after a single intravenous administration in healthy chinese adult subjects. twelve healthy adult subjects will be enrolled in the phase ia program. phase ib design: the purpose of the phase ib clinical study is to evaluate the safety and biodistribution (pet imaging) of patients with malignant solid tumors receiving a single intravenous administration of 68ga-hx01 injection, and to explore the characteristics of tumor imaging. ten patients with malignant solid tumors will be enrolled in phase ib.

Eligibility criteria:
this study consists of two parts: a phase ia study in healthy adult subjects and a phase ib study in patients with malignant solid tumors. phase ia: inclusion criteria: * 18-50 years old; * female weight 45-80kg, male weight 50-80kg; * agree to take effective contraception during the study and for at least three months after the drug administration. exclusion criteria: * pregnant or lactating women; or plan to donate sperm or eggs during the study or within three months after drug administration; * known or suspected allergic to the test drug or any of its components; * receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment; * those who tested positive for hepatitis b/c virus, syphilis or hiv during screening; * clinically significant abnormalities in hematology, blood biochemistry, and urine routine during screening; * patients with clinically significant diseases within 4 weeks before screening; * blood pressure higher than 150/100 mmhg or lower than 90/50 mmhg at screening; * use of any prescription or over-the-counter drugs within 2 weeks before the trial drug administration; * blood donation or blood loss ≥500 ml within 12 weeks before administration; * history of drug or alcohol abuse within 12 months prior to administration; * smoking more than 5 cigarettes a day or consuming the same amount of nicotine or nicotine replacement within 3 months before administration; * history of malignancy; * plan to schedule surgery and other invasive interventions within one week of the test drug injection; * compliance to lie for about 90 minutes during the pet examination. phase ib: inclusion criteria: * patients with malignant solid tumors with measurable lesions (target lesions) confirmed by histopathology or cytology or clinical diagnosis; * 18-75 years old; * eastern cooperative oncology group (ecog) score 0 or 1; * life expectancy ≥6 months; * agree to take effective contraception during the study and for at least three months after the drug administration. exclusion criteria: * pregnant or lactating women; or plan to donate sperm or eggs during the study or within three months after drug administration; * known or suspected allergic to the test drug or any of its components; * receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment; * those who tested positive for hepatitis b/c virus, syphilis or hiv during screening; * any radiotherapeutic drugs used within 90 days before administration, or any radionuclide diagnostic drugs received within 3 days before administration; * plan to schedule surgery and other invasive interventions within 2 days after trial drug injection; * abnormal liver and kidney function: serum total bilirubin (tbil) \> 1.5×uln (upper limit of normal), or aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 2.5×uln, or serum creatinine \> 1.5×uln; * with active infection at the time of screening; * compliance to lie for about 60 minutes during the pet examination.