NL-OMON36432已完成不适用
A phase 1, placebo-controlled, ascending-dose study to assess the safety and imaging characteristics of GE-137 Injection in healthy volunteers, and to assess its safety and imaging characteristics in subjects with high suspicion of colorectal cancer - GE-137-001
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy volunteers:
- •(1) The subject is >=18 and <=70 years old at screening.
- •(2) Female subjects need to be either surgically sterile, post menopausal or pre menopausal with a negative urine pregnancy test.
- •(3) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
- •(4)The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening
- •(5)The subject*s screening ECG and clinical laboratory test results are within normal limits.
- •(6)The subject has negative test results for drug and alcohol screening.
- •(7)The subject*s body mass index is <= 30 but not <18 kg/m2.
- •(8)The subject has negative test results for hepatitis B, hepatitis C, and human immunodeficiency virus.;Subjects with High Suspicion of Colorectal Cancer
- •(1) The subject is >= 45 years old at screening.
- •(2) Female subjects need to be either surgically sterile, post menopausal, or pre menopausal with a negative urine pregnancy test
- •(3) The subject has high suspicion of CRC.
- •(4) The subject is able and willing to comply with study procedures, and signed and dated informed consent is obtained before any study-related procedure is performed.
- •(5) The subject has a normal or clinically acceptable medical history, physical examination, and vital signs findings at screening .
- •(6)The subject*s screening ECG and clinical laboratory tests are within normal limits.
- •(7)The subject*s body mass index is <=30 but not <18 kg/m2.
排除标准
- •Healthy Volunteers
- •(1) If female, the subject is lactating or pregnant.
- •(2) The subject has been previously included in this study.
- •(3) Treatment with another investigational medicinal product (IMP) within 3 months prior to screening or more than 4 times in the past year.
- •(4) Loss of blood outside the limits of Sanquin within 3 months prior to screening.
- •(5) The subject has received any prescription or non-prescription medication regularly between 14 days and 1 day prior to IMP administration. Occasional use of analgesics, such as ibuprofen and paracetamol, etc., is permitted at the discretion of the investigator. Use of hormonal contraceptives is also permitted. ;Subjects with High Suspicion of Colorectal Cancer
- •(1) If female, the subject is lactating or pregnant.
- •(2) The subject is being treated or has been treated with chemotherapy or radiation within the 3 months before enrolment.
- •(3) A biopsy has been obtained from the colon within the 3 weeks before enrolment.
- •(4) The subject has been previously included in this study.
- •(5) Treatment with another IMP within 3 months prior to screening or more than 4 times in the past year.
- •(6) Loss of blood outside the limits of Sanquin within 3 months prior to screening.
- •(7) The subject has had any significant change in their regular prescription or non-prescription medication between 14 days and 1 day prior to IMP administration. Occasional use of analgesics, such as ibuprofen and paracetamol, etc., is permitted at the discretion of the investigator. Use of hormonal contraceptives is also permitted.
- •(8) The subject has a history of alcohol and/or drug abuse within the previous 12 months, based on a review
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