A Clinical Study of 68Ga-HX01 Injection for PET Imaging

A Phase I Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging

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.

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.