Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents

PHASE1CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

June 24, 2024

Primary Completion Date

July 29, 2024

Study Completion Date

September 24, 2024

Conditions
Prostate Cancer Patients Undergoing Radical ProstatectomyProstate 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.

Trial Locations (1)

266000

The Affiliated Hospital of Qingdao University, Qingdao

All Listed Sponsors
lead

Haitao Niu, MD

OTHER

NCT07101354 - Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents | Biotech Hunter | Biotech Hunter