EUCTR2019-002393-31-NL进行中（未招募）1 期
A phase 1a/1b/2a study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer
OnTarget Laboratories0 个研究点目标入组 24 人开始时间: 2019年6月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Healthy volunteers
- •1) Male and 18-65 years old at screening.
- •2) Able and willing to comply with study procedures, with signed and dated informed consent obtained before any study-related procedure is performed.
- •3) Agree to use an effective method of contraception for 90 days after administration.
- •4) A body mass index is =30 kg/m2.
- •5) The subject is healthy with no acute or chronic medical illnesses, has a normal physical examination, and normal vital signs findings at screening.
- •6) The subject’s screening 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the Investigator
- •7) Negative screening test results for hepatitis B, hepatitis C, and human immunodeficiency virus.
- •8) Negative test results for drug and alcohol screening.
- •9) Absence of any psychological, familial, sociological or geographical condition that at the
- •discretion of the investigator could potentially hamper compliance with the study protocol and follow-up schedule; such conditions should be discussed with the patient during the
- •prescreening period.
- •1) Male patients > 18 years of age and older at screening
- •2) Able and willing to comply with study procedures, and signed and dated informed consent is
- •obtained before any study-related procedures are performed.
- •3) Known or high clinical suspicion of primary prostate cancer (Gleason score 7+)
- •planned for a prostatectomy
- •4) Known or high clinical suspicion of prostate cancer scheduled to undergo a pelvic lymph node dissection
- •5) The 12-lead ECG and clinical laboratory test results are within normal limits, or if any are outside of normal limits they are considered clinically insignificant at the discretion of the investigator
- •6) Absence of any psychological, familial, sociological or geographical condition that at the
- •discretion of the investigator could potentially hamper compliance with the study
- •protocol and follow-up schedule; such conditions should be discussed with the patient during the prescreening period.
- •7) Chronic or acute medical illness that in the discretion of the investigator may confound or complicate the findings in this study
- •8) Patients are clinically fit for surgery
- •9) Agree to use an effective method of contraception for 90 days after administration
- •10) Absence of any psychological, familial, sociological or geographical condition that at the
- •discretion of the investigator could potentially hamper compliance with the study protocol and follow-up schedule; such conditions should be discussed with the patient during the
- •prescreening period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 24
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 24
排除标准
- •Healthy volunteers
- •1) Female subjects
- •2) Known acute or chronic disease, abnormal physical examination or blood tests
- •3) The subject has previously been included in an OTL study.
- •4) Use of prescription drugs within 30 days of screening and during study participation
- •5) Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.
- •6) History of clinically significant allergies or anaphylactic reactions.
- •7) History of allergy to any of the components of OTL78 or excipients (see Section 3.2 IB).
- •1) Any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient
- •2) History of clinically significant allergies or anaphylactic reactions.
- •3) History of allergy to any of the components of OTL78 or excipients (see Section 3.2 IB)
- •4) Impaired renal function defined as eGFR<50 ml/min/1.73m2
- •5) Impaired liver function defined as values greater than 3x the upper limit of normal (ULN) for ALT, AST, or 2x the upper limit of normal for total bilirubin (unless due to Gilbert Syndrome)
- •6) Previous participation in an OTL study
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