Clinical trial
A Phase I/IIa Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
Name
INR101-I/IIa-01
Description
Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer.
Trial arms
Trial start
2024-05-23
Estimated PCD
2025-03-31
Trial end
2025-05-30
Status
Recruiting
Phase
Early phase I
Treatment
INR101
• 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT
Arms:
phase I
Other names:
INR101 PET CT
INR101
* 9±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT
* 7±1 mCi of INR101 will be injected intravenously prior to perform the PET/CT
Arms:
phase II
Other names:
INR101 PET CT
Size
32
Primary endpoint
Phase I primary outcome: incidence of adverse events of INR101 injection
7 days after administration
Phase I primary outcome:radiation dosimetry
3 hours after administration
Phase I primary outcome:Tmax (Time to reach maximum plasma concentration)
4 hours after administration
Phase I primary outcome:t1/2 (Elimination half-life)
4 hours after administration
Phase I primary outcome:AUC0-t (Area under the plasma concentration-time curve from time 0 to time t)
4 hours after administration
Phase I primary outcome:AUC0-∞ (Area under the plasma concentration-time curve from time 0 to infinity)
4 hours after administration
Phase I primary outcome:CL (Clearance)
4 hours after administration
Phase I primary outcome:Cmax (Maximum plasma concentration)
4 hours after administration
Phase I primary outcome:SUV-standardized uptake value
3 hours after administration
Phase I primary outcome:%ID/g - percentage of injected dose per gram
3 hours after administration
Phase I primary outcome:residence time - residence time in the the target organs
3 hours after administration
Phase II primary outcome :diagnostic efficacy
28 days after administration
Eligibility criteria
Phase 1 Inclusion Criteria:
1. Males aged ≥18 years old
2. 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
3. Agree to use contraceptive measures from the day of signing the informed consent form until 3 months after drug administration, to avoid sperm donation;
4. The subjects/legally authorized representative/guardian understands the purpose and procedures of the trial, and signs the informed consent form.
Phase 2 Inclusion Criteria:
1. Males aged ≥18 years
2. ECOG score of 0 or 1
3. Subjects who are planned to undergo prostate biopsy for pathological examination after clinical assessment, with no contraindications for biopsy
4. Routine blood tests, liver and kidney function, and coagulation function meet the corresponding conditions
5. Agree to use contraceptive measures from the date of signing the informed consent form to 3 months after medication administration, to avoid sperm donation
6. The subject/legal authorized representative/guardian understands the purpose and procedures of the trial and signs the informed consent form
Phase 1 Exclusion Criteria:
1. Subjects who cannot complete INR101 imaging according to the requirements
2. Subjects who cannot complete pharmacokinetics sample collection according to the requirements
3. 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
4. History of mental illness
5. History of past malignant tumors
6. History of past heart-related diseases
7. History of significant brain diseases in the past
8. Suffering from severe and/or poorly controlled and/or unstable diseases that the researcher judges may affect the study
9. History of bleeding or coagulation disorders
10. History of alcohol abuse or drug abuse/dependency
11. Known allergy to the active ingredients of INR101 or its components
12. Participated in other clinical trials before screening or during screening, or plans to participate in other clinical trials during this study
13. 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:
1. Subjects who are unable to complete the INR101 imaging as required
2. History of any other malignant tumors in the past
3. Subjects in other interventional clinical trials or subjects in clinical trials of radioactive therapeutic drugs before signing the informed consent form
4. Receiving any anti-tumor treatment before drug administration
5. Known allergy to the active ingredients of INR101 or its components Abnormal serum virology examination
6. Researchers judge that there are any medical diseases or other conditions that may affect safety, compliance or may affect the study results.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ESTIMATED'}}
Updated at
2024-06-25
1 organization
1 product
2 indications
Organization
Yunhe Pharmaceutical (Tianjin)Product
INR101Indication
Healthy Male ParticipantsIndication
Prostate Cancer