Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents

Haitao Niu, MD32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Prostate Cancer Patients Undergoing Radical Prostatectomy Prostate CA

Interventions

0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)DRUG

Within the specified time period, conduct dose escalation, and administer the corresponding dose via intravenous drip according to the randomization information.

0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6)DRUG

Within the specified time period, conduct dose escalation, and administer the corresponding dose via intravenous drip according to the randomization information.

0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6)DRUG

Within the specified time period, conduct dose escalation, and administer the corresponding dose via intravenous drip according to the randomization information.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China