A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer
Overview
- Phase
- Phase 1
- Intervention
- rhPSMA-7.3 (18F) Injection
- Conditions
- Prostate Cancer
- Sponsor
- Blue Earth Diagnostics
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
A Phase 1, Open-label Study to Assess Safety, Biodistribution, and Internal Radiation Dosimetry of rhPSMA-7.3 (18F) Injection in Healthy Volunteers, and to Assess Safety and Investigate the Imaging Characteristics in Subjects With Prostate Cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy Volunteers
- •Male and females 21-65 years.
- •Clinically acceptable medical history
Exclusion Criteria
- •Healthy Volunteers
- •Received ionising radiation exposure from clinical trials or medical examinations or treatment in the last 12 months.
- •Suffers from claustrophobia.
- •Bilateral hip prostheses.
- •Key Inclusion Criteria: Patients
- •Male 18-80 years.
- •Histologically confirmed adenocarcinoma of the prostate
- •Clinically acceptable medical history
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Key Exclusion Criteria: Patients
Arms & Interventions
Healthy Volunteers
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Intervention: rhPSMA-7.3 (18F) Injection
Patients
Single intravenous administration of rhPSMA-7.3 (18F) for PET Scan
Intervention: rhPSMA-7.3 (18F) Injection
Outcomes
Primary Outcomes
Number of Participants With Treatment-emergent Adverse Events as Classified by MedDRA
Time Frame: 1 month
Safety will be assessed from data on the occurrence of one or more treatment-emergent Adverse Events from the time of intravenous administration of 18F-rhPSMA-7.3 throughout the study period, and changes in serum biochemistry, hematology, coagulation, urinalysis, vital signs, Electrocardiogram (ECG), injection site status, and physical examination findings.