A Phase I Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Electrocardiogram QRS Interval
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Ia: Low-dose group
The injection dose of 68Ga-HX01 for low-dose group is 0.05 mCi/kg.
干预措施: 68Ga-HX01 Injection(0.05mCi/kg) (Drug)
Ia: High-dose group.
The injection dose of 68Ga-HX01 for the high-dose group is 0.1 mCi/kg.
干预措施: 68Ga-HX01 Injection(0.1mCi/kg) (Drug)
Ib: Patients with malignancy.
The injection dose for phase Ib patients was 0.07 mCi/ kg.
干预措施: 68Ga-HX01 Injection(0.07mCi/kg) (Drug)
结局指标
主要结局
Electrocardiogram QRS Interval
时间窗: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram QRS interval was recorded to assess the effect of 68Ga-HX01 administration.
Respiration
时间窗: Time Frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in respiration rate after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on respiration.
Electrocardiogram QT Interval
时间窗: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram QT interval was recorded to assess the effect of 68Ga-HX01 administration.
Oxygen saturation
时间窗: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in oxygen saturation after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on oxygen saturation.
Electrocardiogram PR Interval
时间窗: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
Electrocardiogram PR interval was recorded to assess the effect of 68Ga-HX01 administration.
Number of Participants With Abnormal Laboratory Values in Blood biochemistry
时间窗: Day 2.
Blood biochemistry of Day 2 was recorded.
Temperature
时间窗: During the screening period (within 7 days), within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in body temperature after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on body temperature.
Pulse
时间窗: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in pulse after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on pulse.
Blood pressure
时间窗: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
Changes in diastolic pressure and systolic pressure after 68Ga-HX01 administration were recorded to analyze the effects of 68Ga-HX01 on blood pressure.
Number of Participants With Abnormal Laboratory Values in Urine routine
时间窗: Day 2.
Urine routine of Day 2 was recorded.
Electrocardiogram T Wave
时间窗: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
The shape of electrocardiogram T wave was recorded to assess the effect of 68Ga-HX01 administration.
Electrocardiogram ST Segment
时间窗: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
The shape of electrocardiogram ST segment was recorded to assess the effect of 68Ga-HX01 administration.
Number of Participants With Abnormal Laboratory Values in Blood routine
时间窗: Day 2.
The blood routine of Day 2 was recorded.
Prothrombin time test and/or a partial thromboplastin time test (PTT)
时间窗: Day 2.
Coagulation function of Day 2 was recorded.
次要结局
- The percentage of injected dose per gram (% ID/g)(Blood samples are collected for the radioactivity determination before (within 30 minutes) and after 68Ga-HX01 injection at different time points (2, 5, 10, 30, 60, 90, 120, and 180 minutes).)
- The max uptake of each lesion(At 30 and 60 minutes after 68Ga-HX01 injection.)
- The mean uptake of each lesion(At 30 and 60 minutes after 68Ga-HX01 injection.)
- Lesion number(At 30 and 60 minutes after 68Ga-HX01 injection.)
- Dosimetry(At 10, 30, 60 and 120 minutes after 68Ga-HX01 injection.)
- The size of each lesion(At 30 and 60 minutes after 68Ga-HX01 injection.)