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OpenTrials
Completed

NCT Number: NCT07101354

Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: DGPR1008, 0.01mg/kg Dose Group 1 (n=6)

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.

Other names: 0.02mg/kg Dose Group 2 (n=6), DGPR1008, Treatment group

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.

Other names: 0.04mg/kg Dose Group 3 (n=6), DGPR1008, Treatment group

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

Drug

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

Other names: DGPR1008, 0.08mg/kg Dose Group 4 (n=6), Treatment group

Dose Group 0 (n=8)

Drug

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.

Other names: placebo control group

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: through study completion, an average of 5 Days

    Incidence of Treatment-Emergent Adverse Events

  2. Number of participants with abnormal vital signs

    Time frame: through study completion, an average of 5 Days

    temperature in ℃

  3. Number of participants with abnormal vital signs

    Time frame: through study completion, an average of 5 Days

    pulse in beats/minute

  4. Number of participants with abnormal vital signs

    Time frame: through study completion, an average of 5 Days

    blood pressure in mmHg

  5. The number of participants with abnormal BMI

    Time frame: through study completion, an average of 5 Days

    Weight and height will be combined to report BMI in kg/m^2

  6. Number pf participants with abnormal laboratory tests results

    Time frame: through study completion, an average of 5 Days

    complete blood count

  7. Number pf participants with abnormal laboratory tests results

    Time frame: through study completion, an average of 5 Days

    blood chemistry panel

  8. Number pf participants with abnormal laboratory tests results

    Time frame: through study completion, an average of 5 Days

    urinalysis

Secondary outcomes

  1. Evaluation indices for pharmacokinetics(Cmax)

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    Cmax

  2. Evaluation indices for pharmacokinetics(AUC(0-t))

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    AUC(0-t)

  3. Evaluation indices for pharmacokinetics(AUC(0-∞))

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    AUC(0-∞)

  4. Evaluation indices for pharmacokinetics(AUC_%Extrap)

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    AUC_%Extrap

  5. Evaluation indices for pharmacokinetics(t1/2)

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    t1/2

  6. Evaluation indices for pharmacokinetics(CL)

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    CL

  7. Evaluation indices for pharmacokinetics(CLRenal)

    Time frame: PK Urine Samples:Pre-dose (within 120 minutes before dosing); During dosing (from start to end of infusion), Post-dose time intervals: 0-2hours, 2-4hours, 4-8hours, 8-12hours, 12-24hours, 24-48 hours.

    CLRenal

  8. Evaluation indices for pharmacokinetics

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    λz

  9. Evaluation indices for pharmacokinetics(Vz)

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    Vz

  10. Evaluation indices for pharmacokinetics(MRT(0-t)、MRT(0-∞))

    Time frame: PK Blood Samples:Pre-dose (within 60 minutes before dosing);Immediately after dosing completion (within 2 minutes),5 minutes(±2 minutes) and 15minutes (±3 minutes) and 30minutes (±5 minutes) and(1, 2, 4, 6, 8, 24 hours)(±30 minutes) post-dose.

    (MRT(0-t)、MRT(0-∞))

Sponsors and collaborators

Lead sponsor

Haitao Niu, MD

Other

Registry information

Official study title

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

Acronym: DGPR1008

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2025
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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