NL-OMON21822
招募中
不适用
A phase 1 a/1 b/2 study to assess the safety, tolerability and pharmacokinetics of OTL78, a PSMA-targeted fluorescent agent, for the intraoperative imaging of prostate cancer
On Target Laboratories, Inc0 个研究点目标入组 39 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- On Target Laboratories, Inc
- 入组人数
- 39
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
.A.
研究者
入排标准
入选标准
- •Part A (healthy volunteers)
- •Ten (n\=10\) healthy volunteers will take part in this study (maximum\=15 if a 3rd dosing cohort is added).
- •Inclusion criteria
- •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 procedures are 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.
排除标准
- •Healthy volunteers (phase 1 a/1 b)
- •1\) Female subjects
- •2\) Known acute or chronic disease, abnormal physical examination or blood tests of clinical significance.
- •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 Investigator's Brochure).
- •Part B / Part C
- •Patients will be excluded if any of the criteria below apply:
结局指标
主要结局
未指定
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