JPRN-jRCT2022230014
Recruiting
Phase 1
Phase I/IIa clinical trial to evaluate the safety, pharmacokinetics, and internal dose of Ga-68 PSMA-11 injection solution produced by the MPS200 PSMA-Ga automated synthesizer and to explore its efficacy in healthy adult males and prostate cancer patients
Shiga Tohru0 sites9 target enrollmentJuly 1, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shiga Tohru
- Enrollment
- 9
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Japanese males aged 18 years and older but under 65 years
- •Non\-smoker
- •BMI between 18 kg/m2 and 28 kg/m2
- •Main laboratory values (blood, liver function, renal function, electrolytes, urine) are within normal range.
- •(Common to Step 2 and Step 3\)
- •Age 18 years or older and less than 80 years old
- •Patients with histologically diagnosed prostate cancer
- •BMI between 18 kg/m2 and 28 kg/m2
- •ECOG PS between 0 and 2
- •Main laboratory tests (blood, liver and kidney function) are well maintained and within reference values.
Exclusion Criteria
- •1\) Patients with a history of hypersensitivity to any drug or alcohol.
- •2\) Have a contraindication to PET/CT examination (e.g., claustrophobia).
- •3\) Patients with a disease or trauma that may affect pharmacokinetics.
- •4\) Require treatment for prostate cancer other than hormonal therapy within 7 days of receiving the investigational drug.
- •5\) Patients must have any of the following infectious diseases and must receive treatment during the study period
- •Hepatitis B virus infection
- •Hepatitis C virus infection
- •HIV infection
- •4\) Other infectious diseases requiring systemic treatment
- •6\) Unable to agree to use contraception for 3 months after receiving the investigational drug.
Outcomes
Primary Outcomes
Not specified
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