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NCT07101354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-03

No results posted yet for this study

Summary

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.

Conditions

  • Prostate Cancer Patients Undergoing Radical Prostatectomy
  • Prostate CA

Interventions

DRUG

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

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

DRUG

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

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

DRUG

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

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

DRUG

0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6)

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

DRUG

Dose Group 0 (n=8)

Within the specified time frame, dose escalation will be conducted. Intravenous infusions will be administered according to randomization, with subjects receiving either the corresponding dose or placebo.

Sponsors & Collaborators

  • Haitao Niu, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2024-07-29
Completion
2024-09-24

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07101354 on ClinicalTrials.gov