Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents

NCT07101354 | Completed Phase 1

• 2 other identifiers: QYFYEC2024-047-01CXHL2400243
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (8)

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  through study completion, an average of 5 Days

• Number of participants with abnormal vital signs

  temperature in ℃

  through study completion, an average of 5 Days

• Number of participants with abnormal vital signs

  pulse in beats/minute

  through study completion, an average of 5 Days

• Number of participants with abnormal vital signs

  blood pressure in mmHg

  through study completion, an average of 5 Days

• The number of participants with abnormal BMI

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

  through study completion, an average of 5 Days

• Number pf participants with abnormal laboratory tests results

  complete blood count

  through study completion, an average of 5 Days

• Number pf participants with abnormal laboratory tests results

  blood chemistry panel

  through study completion, an average of 5 Days

• Number pf participants with abnormal laboratory tests results

  urinalysis

  through study completion, an average of 5 Days

Secondary Outcomes (10)

• Evaluation indices for pharmacokinetics(Cmax)

  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.

• Evaluation indices for pharmacokinetics(AUC(0-t))

  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.

• Evaluation indices for pharmacokinetics(AUC(0-∞))

  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.

• Evaluation indices for pharmacokinetics(AUC_%Extrap)

  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.

• Evaluation indices for pharmacokinetics(t1/2)

  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.

Study Arms (5)

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

EXPERIMENTAL

On the day of administration, subjects will be randomized to receive the DGPR1008 Injection (0.01 mg/kg; n=6) via slow IV infusion over 60-90 minutes. Infusion Monitoring: Closely assess for infusion reactions; discontinue if necessary. Post-Infusion: Inspect injection site for erythema, pruritus, etc. Protocol Adherence: Conduct bio-sample collection, safety checks, and document all adverse events/concomitant therapies.

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

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

EXPERIMENTAL

On the day of administration, subjects will be randomized to receive the investigational product (0.02 mg/kg; n=6) via slow IV infusion over 60-90 minutes. Infusion Monitoring: Closely assess for infusion reactions; discontinue if necessary. Post-Infusion: Inspect injection site for erythema, pruritus, etc. Protocol Adherence: Conduct bio-sample collection, safety checks, and document all adverse events/concomitant therapies.

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

Dose Group 0 (n=8)

PLACEBO COMPARATOR

On the day of administration, subjects will be randomized to receive placebo (n=8) via slow IV infusion over 60-90 minutes. Infusion Monitoring: Closely assess for infusion reactions; discontinue if necessary. Post-Infusion: Inspect injection site for erythema, pruritus, etc. Protocol Adherence: Conduct bio-sample collection, safety checks, and document all adverse events/concomitant therapies.

Drug: Dose Group 0 (n=8)

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

ACTIVE COMPARATOR

On the day of administration, subjects will be randomized to receive the investigational product (0.04 mg/kg; n=6) via slow IV infusion over 60-90 minutes. Infusion Monitoring: Closely assess for infusion reactions; discontinue if necessary. Post-Infusion: Inspect injection site for erythema, pruritus, etc. Protocol Adherence: Conduct bio-sample collection, safety checks, and document all adverse events/concomitant therapies.

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

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

ACTIVE COMPARATOR

On the day of administration, subjects will be randomized to receive the DGPR1008 Injection (0.08 mg/kg; n=6) via slow IV infusion over 60-90 minutes. Infusion Monitoring: Closely assess for infusion reactions; discontinue if necessary. Post-Infusion: Inspect injection site for erythema, pruritus, etc. Protocol Adherence: Conduct bio-sample collection, safety checks, and document all adverse events/concomitant therapies.

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

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.

Also known as: DGPR1008, 0.01mg/kg Dose Group 1 (n=6)

0.01mg/kg DGPR1008 Injection 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.

Also known as: 0.02mg/kg Dose Group 2 (n=6), DGPR1008, Treatment group

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

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.

Also known as: 0.04mg/kg Dose Group 3 (n=6), DGPR1008, Treatment group

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

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.

Also known as: DGPR1008, 0.08mg/kg Dose Group 4 (n=6), Treatment group

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

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.

Also known as: placebo control group

Dose Group 0 (n=8)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haitao Niu, MD: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: August 3, 2025
• Study Start: June 24, 2024
• Primary Completion: July 29, 2024
• Study Completion: September 24, 2024
• Last Updated: August 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF

Locations

CN (1)