Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents

A Phase I/Ⅱa, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer

Phase I:

Primary Research Objective:

Evaluate the safety, tolerability, and pharmacokinetic characteristics of a single dose of DGPR1008 in healthy subjects.

Secondary Research Objective:

Based on the safety and pharmacokinetic results, assess the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D) of DGPR1008.

Inclusion Criteria:

• Provide signed informed consent prior to the trial, and fully understand the trial content, procedures, and potential adverse reactions.
• Be able to complete the study as required by the trial protocol.
• Be an adult male aged 18-65 years (inclusive).
• Have a body weight ≥50 kg and a body mass index (BMI) of 18-30 kg/m² (calculated as BMI = weight [kg]/height² [m²]).
• Neither the subject nor their partner/spouse plan to conceive or donate sperm from screening until 3 months after the trial completion, and agree to use effective non-pharmacological contraception during the study.

Exclusion Criteria:

Subjects will be excluded if any of the following apply:

• Clinically significant abnormalities (physical exam, vital signs, ECG, labs) or severe medical history (cardiac, hepatic, renal, GI, neurological, respiratory, psychiatric, metabolic) deemed unsuitable by the investigator.
• History of allergy (≥2 drugs/foods, milk/pollen), or allergy to investigational drug/components.
• Alcohol abuse (>14 units/week) in prior 3 months or positive breathalyzer.
• Positive serology for HBsAg, anti-HCV, anti-HIV, or syphilis.
• Positive urine drug screen, drug abuse history (past 5 years), or illicit drug use (past 3 months).
• Blood loss >400 mL or platelet donation (2 therapeutic units) in prior 3/1 months, respectively.
• Smoking >5 cigarettes/day (past 3 months) and inability to abstain.
• Surgery within prior 3 months.
• Participation in another clinical trial (investigational product) within prior 3 months.
• Prescription medication use within prior 1 month.
• OTC drugs, herbal supplements, or vitamins within prior 48 hours.
• Other conditions deemed unsuitable by the investigator.