A Phase I/IIa Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Phase I primary outcome: incidence of adverse events of INR101 injection
研究概览
简要总结
Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer.
详细描述
A multi-center, prospective, open-label, randomized Phase I/II diagnostic study designed for the management of healthy male subjects and patients with suspected prostate cancer.
Phase I Study Objective: The primary goal is to assess the biodistribution, dosimetry, pharmacokinetic (PK) attributes, and safety profile of INR101 injections in healthy Chinese male subjects. The specific endpoints include evaluating the safety, Standardized Uptake Value (SUV), Accumulation (%ID), Retention Time, Absorbed Dose, Effective Dose, and PK parameters in whole blood, plasma, and urine following an intravenous administration of INR101.
Phase II Study Objective: This phase aims to determine the diagnostic efficacy of INR101 injection PET/CT scans in patients with suspected prostate cancers. The principal aim is to ascertain the optimal imaging conditions, which involve determining the best dose and timing of administration. This will be gauged based on the diagnostic performance metrics-sensitivity, specificity, and accuracy-of the INR101 injection PET/CT at different dosages and imaging intervals, using prostate biopsy pathology results as the reference standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged ≥18 years old
- •Good health status or no major illness, judged by the investigator based on the following assessments: medical history, physical examination, vital signs, 12-lead electrocardiogram, laboratory tests that are normal or abnormal but not clinically significant
- •Agree to use contraceptive measures from the day of signing the informed consent form until 3 months after drug administration, to avoid sperm donation;
- •The subjects/legally authorized representative/guardian understands the purpose and procedures of the trial, and signs the informed consent form.
- •Phase 2 Inclusion Criteria:
- •Males aged ≥18 years
- •ECOG score of 0 or 1
- •Subjects who are planned to undergo prostate biopsy for pathological examination after clinical assessment, with no contraindications for biopsy
- •Routine blood tests, liver and kidney function, and coagulation function meet the corresponding conditions
- •Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, to avoid sperm donation
- •The subject/legal authorized representative/guardian understands the purpose and procedures of the trial and signs the informed consent form
排除标准
- •Subjects who cannot complete INR101 imaging according to the requirements
- •Subjects who cannot complete pharmacokinetics sample collection according to the requirements
- •Serum virology examination (Heptitis B surface antigen,Anti-Treponema pallidum antibody,HIV antibodies,Antibody to Hepatitis C Virus) is abnormal, which is judged by the researchers to have clinical significance
- •History of mental illness
- •History of past malignant tumors
- •History of past heart-related diseases
- •History of significant brain diseases in the past
- •Suffering from severe and/or poorly controlled and/or unstable diseases that the researcher judges may affect the study
- •History of bleeding or coagulation disorders
- •History of alcohol abuse or drug abuse/dependency
- •Known allergy to the active ingredients of INR101 or its components
- •Participated in other clinical trials before screening or during screening, or plans to participate in other clinical trials during this study
- •The researcher judges that there are any medical diseases or other conditions that may affect safety, compliance or may affect the results of the study
- •Phase 2 Exclusion Criteria:
- •Subjects who are unable to complete the INR101 imaging as required
- •History of any other malignant tumors in the past
- •Subjects in other interventional clinical trials or subjects in clinical trials of radioactive therapeutic drugs before signing the informed consent form
- •Receiving any anti-tumor treatment before drug administration
- •Known allergy to the active ingredients of INR101 or its components Abnormal serum virology examination
- •Researchers judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.
研究组 & 干预措施
phase I
Experimental: INR101 PET/ CT
Drug: INR101.
干预措施: INR101 (Drug)
phase II
Experimental: INR101 PET/ CT
Interventions:
Drug: INR101
干预措施: INR101 (Drug)
结局指标
主要结局
Phase I primary outcome: incidence of adverse events of INR101 injection
时间窗: 7 days after administration
Treatment-emergent adverse events (AEs) will be assessed and graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Phase I primary outcome:AUC0-∞ (Area under the plasma concentration-time curve from time 0 to infinity)
时间窗: 4 hours after administration
Assessment of INR101 AUC0-∞ in whole blood 4 hours after administration
Phase I primary outcome:CL (Clearance)
时间窗: 4 hours after administration
Assessment of INR101 CL in whole blood 4 hours after administration
Phase I primary outcome:%ID/g - percentage of injected dose per gram
时间窗: 3 hours after administration
Assessment of INR101 uptake by PET scan by measuring percentage of injected dose per gram of tissue in the target organs
Phase I primary outcome:AUC0-t (Area under the plasma concentration-time curve from time 0 to time t)
时间窗: 4 hours after administration
Assessment of INR101 AUC0-t in whole blood 4 hours after administration
Phase I primary outcome:Cmax (Maximum plasma concentration)
时间窗: 4 hours after administration
Assessment of INR101 Cmax in whole blood 4 hours after administration
Phase I primary outcome:SUV-standardized uptake value
时间窗: 3 hours after administration
Assessment of INR101 uptake by PET scan by measuring standardized uptake value in the target organs.
Phase I primary outcome:residence time - residence time in the the target organs
时间窗: 3 hours after administration
Assessment of INR101 uptake by PET scan by measuring residence time in the target organs
Phase I primary outcome:radiation dosimetry
时间窗: 3 hours after administration
Mean absorbed radiation doses were estimated using the source and target organ framework. Eight health subjects underwent serial INR 101 PET/CT scans at three time points following radiotracer injection: 5±5 min，30±5 min，60±10 min，120±10 min，180±20 min.
Phase I primary outcome:Tmax (Time to reach maximum plasma concentration)
时间窗: 4 hours after administration
Assessment of INR101 Tmax in whole blood 4 hours after administration
Phase I primary outcome:t1/2 (Elimination half-life)
时间窗: 4 hours after administration
Assessment of INR101 t1/2 in whole blood 4 hours after administration
Phase II primary outcome :diagnostic efficacy
时间窗: 28 days after administration
The sensitivity, specificity, and accuracy of INR101 PET/CT
次要结局
- Phase II secondary outcome: Incidence of adverse events of INR101 injection(7 days after administration)