Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents
NCT ID: NCT07101354
Last Updated: 2025-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2024-06-24
2024-09-24
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
QUADRUPLE
Study Groups
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0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)
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.
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.
0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6)
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.
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.
Dose Group 0 (n=8)
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.
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.
0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6)
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.
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.
0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6)
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.
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.
Interventions
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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.
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
MALE
Yes
Sponsors
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Haitao Niu, MD
OTHER
Responsible Party
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Haitao Niu, MD
Clinical Professor
Locations
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The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Countries
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Other Identifiers
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CXHL2400243
Identifier Type: OTHER
Identifier Source: secondary_id
QYFYEC2024-047-01
Identifier Type: -
Identifier Source: org_study_id
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