A Phase 1 Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Organ-level dosimetry of CSB-111 and total body and effective dose
研究概览
简要总结
Phase one study to evaluate the safety and dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in healthy human volunteers.
详细描述
This study aims to assess the safety and evaluate the dosimetry of CSB-111. This study will estimate organ dosimetry and the overall effective dose, a requirement for expanding the human use of a radiopharmaceutical.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female healthy participants aged between 18 and 65 years old.
- •For females of childbearing potential, a negative serum or urine beta-human chorionic gonadotropin (β-hCG) pregnancy test must be obtained at the day of the procedure prior to CSB-111 administration.
- •Willing and able to undergo all study procedures.
- •Willing and able to understand the written informed consent and sign the consent document prior to any study-related procedure.
- •Willing to refrain from strenuous exercise for the 24 hours prior to CSB-111 administration
排除标准
- •History of allergic reactions to compounds of similar chemical or biologic composition to CSB-
- •Prior malignancy except for fully resected skin cancers.
- •Current treatment with systemic steroids, or immunosuppressive agents.
- •Known renal or hepatic disease.
- •Laboratory values:
- •Leukocytes <3000/mcL
- •Absolute neutrophil count <1500 mcL
- •Platelets <100,000 mcL
- •Total bilirubin >1.5 x Upper limit of normal (ULN)
- •Aspartate Transaminase (AST)/ Alanine Aminotransferase (ALT) >2.5 x ULN
- •Albumin <3.7 g/dL
- •Gamma glutamyl transferase (GGT) >2.5 ULN
- •eGFR <60 mL/min/1.73 m2 measured in the prior 30 days before administration of CSB-111
- •Having received any investigational product in the prior three months of receiving CSB-
- •Currently participating in any clinical trials, except observational studies.
- •Any acute or chronic inflammatory disease, autoimmune disorders, or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results such as infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
- •Participants who have any condition that would prevent them from receiving a PET scan.
- •Female participants who are pregnant (confirmed via a positive serum or urine β-hCG test on the day of procedure prior to CSB-111 administration).
- •Female participants who are breastfeeding.
- •Unable or unwilling to use adequate contraception prior to study, during study participation and for one week post-injection for both females and males.
- •Any medical condition which, in the opinion of the investigator, may interfere with participation in the study and/or alter the biodistribution of CSB-
- •Mentally incapacitated or unable to understand the informed consent.
- •Participants who, in the opinion of the investigator, have underlying psychological conditions which may negatively impact their wellbeing if participating.
- •Staff and family members of CytoSite.
- •Staff reporting to the principal investigator (PI).
研究组 & 干预措施
[68Ga]-NOTA-hGZP (CSB-111) Injection
Eligible participants will receive a single IV injection of CSB-111 up to 40 micro grams
干预措施: CSB-111 (Drug)
结局指标
主要结局
Organ-level dosimetry of CSB-111 and total body and effective dose
时间窗: PET/CT imaging up to 180 minutes post-injection
milli-Sieverts \[mSi\]
Percentage of intact CSB-111 in blood samples up to 185 min after injection, using HPLC
时间窗: From 65 to 185 minutes after injection
Intact CSB-111 percentage in blood
Total radioactivity via gamma counter of cell pellet, plasma protein and unbound radioactivity in blood samples up to 65 min
时间窗: Up to to 185 minutes post dose
milli-Curies \[mCi\]
Concentration of intact CSB-111 in urine
时间窗: up to 4 hours after injection or until below the level of detection
Intact CSB-111 in urine in picograms
Percentage of intact CSB-111 in urine
时间窗: up to 4 hours after injection or until below the level of detection
Percentage of intact CSB-111 in urine compared to initial dose
次要结局
- Overall AEs frequency and frequency per grade of AEs related to CSB-111 according to Medical Dictionary for Regulatory Activities (MedDRA)/ Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0(up to 2 days post dose)