Clinical trial NCT06472531: A Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
Official title: A Phase I/IIa Study of PET/CT Imaging Using INR101 Injection in Healthy Male Subjects and Patients With Suspected Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy Male Subjects
Suspected Prostate Cancer
Lead sponsor: Yunhe Pharmaceutical (Tianjin) Co., Ltd
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Phase I/II study in the management of Healthy Male Subjects and patients with suspected prostate cancer.

Detailed description: 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.

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.

Primary outcomes:
measure: Phase I primary outcome: incidence of adverse events of INR101 injection
timeFrame: 7 days after administration
measure: Phase I primary outcome:radiation dosimetry
timeFrame: 3 hours after administration
measure: Phase I primary outcome:Tmax (Time to reach maximum plasma concentration)
timeFrame: 4 hours after administration
measure: Phase I primary outcome:t1/2 (Elimination half-life)
timeFrame: 4 hours after administration
measure: Phase I primary outcome:AUC0-t (Area under the plasma concentration-time curve from time 0 to time t)
timeFrame: 4 hours after administration
measure: Phase I primary outcome:AUC0-∞ (Area under the plasma concentration-time curve from time 0 to infinity)
timeFrame: 4 hours after administration
measure: Phase I primary outcome:CL (Clearance)
timeFrame: 4 hours after administration
measure: Phase I primary outcome:Cmax (Maximum plasma concentration)
timeFrame: 4 hours after administration
measure: Phase I primary outcome:SUV-standardized uptake value
timeFrame: 3 hours after administration
measure: Phase I primary outcome:%ID/g - percentage of injected dose per gram
timeFrame: 3 hours after administration
measure: Phase I primary outcome:residence time - residence time in the the target organs
timeFrame: 3 hours after administration
measure: Phase II primary outcome :diagnostic efficacy
timeFrame: 28 days after administration
Secondary outcomes:
measure: Phase II secondary outcome: Incidence of adverse events of INR101 injection
timeFrame: 7 days after administration
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Yunhe Pharmaceutical (Tianjin) Co., Ltd.
state: Tianjin
Study officials:
affiliation: The First Medical Center of the General Hospital of the Chinese People's Liberation Army
name: Jinming Zhang, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Friendship Hospital
name: Jigang Yang, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital
name: Fugeng Liu, BD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Xuejuan Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: