NCT05775601已完成早期 1 期
A Phase 1, Open-label Study to Evaluate the Biodistribution and Safety of 18F-LY3950321 (18F-MNI-1256) in Healthy Subjects
Avid Radiopharmaceuticals1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年2月28日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- 18F-LY3950321 Whole Body Effective Dose
研究概览
简要总结
18F-LY3950321 (also known as 18F-MNI-1256) is a radiolabeled positron emission tomography (PET) tracer targeting granzyme B. The overall goal of this protocol is to evaluate the safety, tolerability, and radiation dosimetry of 18F-LY3950321.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy with no clinically relevant finding on physical examination at Screening and upon reporting to the clinic for the Imaging Visit.
- •Female subjects must not be of childbearing potential, or if they are of childbearing potential to agree to use contraception and not donate eggs.
- •Male subjects with their partners of childbearing potential must commit to the use of 2 methods of contraception, 1 of which is a barrier method for male subjects for the study duration and 90 days after study completion.
- •Male subjects must not donate sperm for the study duration and for 90 days after study completion.
排除标准
- •Current or prior history of any alcohol or drug abuse in the past 2 years.
- •Currently exposed to nicotine products or had regular nicotine exposure within a six-month period, to be verified by urine cotinine screening.
- •ECG or Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
- •Known history of hypersensitivity, including hypersensitivity to the active substances used for 18F-LY3950321 or derivatives, or to any of the associated excipients.
- •Subject has received an investigational drug within 30 days or five half-lives prior to Day 1, whichever is longer.
- •Prior participation in other research protocols or clinical care during the past year that would result in radiation exposure to an effective radiation dose exceeding the acceptable annual limit established by the US Federal Guidelines (effective dose of 50 milliSieverts, including the procedures in this clinical protocol).
- •Pregnant, lactating or breastfeeding.
- •Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- •Unsuitable veins for repeated venipuncture.
- •Use of any prescription drugs (except approved forms of birth control) or herbal supplements, within 4 weeks prior to Day
- •Use of any over-the-counter (OTC) medication or dietary supplements (vitamins included) within 2 weeks prior to Day
- •Subject is, in the opinion of the Investigator, unsuitable in any other way to participate in this study.
研究组 & 干预措施
18F-LY3950321 Whole Body Dosimetry
Experimental
干预措施: 18F-LY3950321 (Drug)
18F-LY3950321 Whole Body Dosimetry
Experimental
干预措施: PET Scan (Procedure)
结局指标
主要结局
18F-LY3950321 Whole Body Effective Dose
时间窗: injection to 4 hours postdose
Radiation dose estimates. Distribution data will be utilized in the MIRD calculations of target organ radiation absorbed dose with correction from urine assays and standard GI kinetic models in Organ Level Internal Dose Assessment (OLINDA). Standard Medical Internal Radiation Dose (MIRD) assumptions will be incorporated in dosimetry models for determination of radiation absorbed doses in target organs and whole-body.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
撤回
早期 1 期
Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue SarcomaStage II Adult Soft Tissue SarcomaStage IIA Adult Soft Tissue SarcomaStage IIB Adult Soft Tissue SarcomaStage IIC Adult Soft Tissue SarcomaStage III Adult Soft Tissue SarcomaStage IV Adult Soft Tissue SarcomaNCT03613259OHSU Knight Cancer Institute
已完成
不适用
18F-fluorodeoxyglucose (18F-FDG) Positron Emission Tomography in OncologyBrain NeoplasmsLung NeoplasmsLymphomaColorectal NeoplasmsMelanomaNCT00207298British Columbia Cancer Agency39,242
招募中
1 期
Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTFBreast CarcinomaOvarian CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaSolid NeoplasmFallopian Tube CarcinomaPrimary Peritoneal CarcinomaNCT03604315M.D. Anderson Cancer Center300
已完成
不适用
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical ProstatectomyAdenocarcinoma of the ProstateNCT02523924Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins50
已完成
3 期
Fluciclovine (18F) PET/CT in biochemicAL reCurrence Of Prostate caNcerCancer of the ProstateNCT02578940Blue Earth Diagnostics104