Prostate Cancer Patients Undergoing Radical ProstatectomyPhase 1DGPR1008NCT07101354
Research on PSMA-Targeted Intraoperative Fluorescent Imaging Agents
A Phase 1 study testing 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6), 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6) and 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6) in people with Prostate Cancer Patients Undergoing Radical Prostatectomy and Prostate CA, run by Haitao Niu, MD at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer Patients Undergoing Radical Prostatectomy, Prostate CA
- What is being tested?
- 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6), 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6) and 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2024to 24 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
About this study
Official title: A Phase I/Ⅱa, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer
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.
- Being tested
- 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6), 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6), 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6), 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6), Dose Group 0 (n=8)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)Drug
Also called DGPR1008, 0.01mg/kg 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)Drug
Also called 0.02mg/kg Dose Group 2 (n=6), DGPR1008, Treatment group
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)Drug
Also called 0.04mg/kg Dose Group 3 (n=6), DGPR1008, Treatment group
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)Drug
Also called DGPR1008, 0.08mg/kg Dose Group 4 (n=6), Treatment group
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)Drug
Also called placebo control group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: through study completion, an average of 5 Days
Number of participants with abnormal vital signs
temperature in ℃
Measured: through study completion, an average of 5 Days
Number of participants with abnormal vital signs
pulse in beats/minute
Measured: through study completion, an average of 5 Days
Number of participants with abnormal vital signs
blood pressure in mmHg
Measured: 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
Measured: through study completion, an average of 5 Days
Number pf participants with abnormal laboratory tests results
complete blood count
Measured: through study completion, an average of 5 Days
Number pf participants with abnormal laboratory tests results
blood chemistry panel
Measured: through study completion, an average of 5 Days
Number pf participants with abnormal laboratory tests results
urinalysis
Measured: through study completion, an average of 5 Days
Secondary outcomes (10)
Evaluation indices for pharmacokinetics(Cmax)
Cmax
Measured: 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))
AUC(0-t)
Measured: 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-∞))
AUC(0-∞)
Measured: 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)
AUC_%Extrap
Measured: 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)
t1/2
Measured: 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(CL)
CL
Measured: 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(CLRenal)
CLRenal
Measured: 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.
Evaluation indices for pharmacokinetics
λz
Measured: 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(Vz)
Vz
Measured: 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（MRT(0-t)、MRT(0-∞)）
（MRT(0-t)、MRT(0-∞)）
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start24 Jun 2024
- Primary completion29 Jul 2024
- Study completion24 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer Patients Undergoing Radical ProstatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haitao Niu, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haitao Niu, MD, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101354
- Sponsor's protocol ID
- QYFYEC2024-047-01
- Other IDs
- CXHL2400243
- Acronym
- DGPR1008
- Status last verified
- Jun 2025
- First submitted
- 18 May 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ⅱa, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer
- ClinicalTrials.gov ID
- NCT07101354
- Acronym / sponsor ID
- DGPR1008 / QYFYEC2024-047-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Haitao Niu, MDUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 24 Sep 2024 (actual)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6) | Experimental | Drug: 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. |
| 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6) | Experimental | Drug: 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. |
| Dose Group 0 (n=8) | Placebo comparator | Drug: 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. |
| 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6) | Active comparator | Drug: 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. |
| 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6) | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6)Also: DGPR1008, 0.01mg/kg 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 | 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6) |
| 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6)Also: 0.02mg/kg Dose Group 2 (n=6), DGPR1008, Treatment groupWithin 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) |
| 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6)Also: 0.04mg/kg Dose Group 3 (n=6), DGPR1008, Treatment groupWithin 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) |
| 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6)Also: DGPR1008, 0.08mg/kg Dose Group 4 (n=6), Treatment groupWithin 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) |
| Dose Group 0 (n=8)Also: placebo control groupWithin 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. | Drug | Dose Group 0 (n=8) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, an average of 5 Days
Incidence of Treatment-Emergent Adverse Events
Number of participants with abnormal vital signs
Time frame: through study completion, an average of 5 Days
temperature in ℃
Number of participants with abnormal vital signs
Time frame: through study completion, an average of 5 Days
pulse in beats/minute
Number of participants with abnormal vital signs
Time frame: through study completion, an average of 5 Days
blood pressure in mmHg
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
Number pf participants with abnormal laboratory tests results
Time frame: through study completion, an average of 5 Days
complete blood count
Number pf participants with abnormal laboratory tests results
Time frame: through study completion, an average of 5 Days
blood chemistry panel
Number pf participants with abnormal laboratory tests results
Time frame: through study completion, an average of 5 Days
urinalysis
10 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6), 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6) and 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6) in people with Prostate Cancer Patients Undergoing Radical Prostatectomy and Prostate CA, run by Haitao Niu, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: through study completion, an average of 5 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.