A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer

A regiszterben nem jelölt feltételek

• Phase 1 Inclusion Criteria:
• 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
  • Phase 1 Exclusion Criteria:
• 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.