A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspe… (NCT06472531) | Clinical Trial Compass
CompletedPhase 1/2
A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
China32 participantsStarted 2024-05-23
Plain-language summary
Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer.
Who can participate
Age range18 Years
SexMALE
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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.
✓. 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
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
What they're measuring
1
Phase I primary outcome: incidence of adverse events of INR101 injection
Timeframe: 7 days after administration
2
Phase I primary outcome:radiation dosimetry
Timeframe: 3 hours after administration
3
Phase I primary outcome:Tmax (Time to reach maximum plasma concentration)
Timeframe: 4 hours after administration
4
Phase I primary outcome:t1/2 (Elimination half-life)
Timeframe: 4 hours after administration
5
Phase I primary outcome:AUC0-t (Area under the plasma concentration-time curve from time 0 to time t)
Timeframe: 4 hours after administration
6
Phase I primary outcome:AUC0-∞ (Area under the plasma concentration-time curve from time 0 to infinity)
Timeframe: 4 hours after administration
7
Phase I primary outcome:CL (Clearance)
Timeframe: 4 hours after administration
8
Phase I primary outcome:Cmax (Maximum plasma concentration)