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| ID | Type | Description | Link |
|---|---|---|---|
| CXHL2400243 | Other Identifier | NMPA |
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a single-arm, open-label, multi-center study to evaluate safety, tolerability, pharmacokinetics, and the effectiveness of near-infrared fluorescence imaging during surgery.
We plan to enroll 24 prostate cancer patients and divide them into 2 dosage groups. Intravenous administration will be conducted 24 hours before surgery. Blood samples will be collected for relevant tests, and fluorescence imaging will be performed during the operation. After surgery, the intraoperative imaging results will be compared with pathological findings to draw relevant conclusions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The first dose group | Experimental | Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. |
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| The second dose group | Experimental | Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.02mg/kg | Drug | Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of single-dose administration of DGPR1008 in patients | Adverse event collection, including (such as the location, nature, and frequency of pain), physical signs (such as the scope of rash, blood pressure values), laboratory abnormal values and units (such as ALT 200 U/L), etc. | From the screening period to the day before withdrawal on Day 3 of the trial |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞) in the blood of 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the maximum plasma concentration (Cmax) in the blood of 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the area under the plasma concentration-time curve from time 0 to time t (AUC₀-t) in the blood of 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of the detection by DGPR1008 in conjunction with the near-infrared fluorescence imaging device for intraoperative imaging in patients. | Evaluate the sensitivity, specificity, false positive rate, false negative rate of DGPR1008 in detecting prostate cancer cells or tissues in near-infrared imaging, and assess the tumor-to-background ratio. | 24 hours before the surgery |
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Inclusion Criteria:
Adult male subjects aged ≥18 years. Subjects with pathologically confirmed prostate cancer (Gleason score ≥7) via pre - operative prostate biopsy, scheduled for radical prostatectomy.
No significant liver or kidney impairment: liver - total bilirubin ≤2×ULN (except Gilbert syndrome), ALT/AST ≤3×ULN; kidney - creatinine clearance rate ≥50 mL/min/1.73m² (simplified MDRD).
No surgical contraindications; suitable for laparoscopic radical prostatectomy as determined by the investigator.
Subject and partner/spouse agree to avoid conception and sperm donation from screening until 3 months post - trial, and use effective contraception.
Exclusion Criteria:
Allergic constitution (history of allergy to ≥2 drugs), prone to allergic reactions, or allergic to the investigational drug (including components).
Clinically significant abnormal screening results affecting the study, or serious concomitant diseases (except stable cases approved by the investigator).
Participation in other clinical trials and received investigational products within 1 month before study drug administration.
Other conditions deemed unsuitable for enrollment by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266031 | China |
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| ID | Term |
|---|---|
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 0.04mg/kg | Drug | Slowly infuse intravenously 24 hours before the scheduled surgery. The investigator shall conduct near-infrared fluorescence imaging during the operation to assist with the surgery. Tissues detected with fluorescence need to be marked, and resection shall be guided by fluorescence until there is no fluorescent tissue within the surgical field. |
|
|
To measure the percentage of extrapolated area under the plasma concentration-time curve (AUC%Extrap) in the blood of 24 subjects |
| PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the plasma elimination half-life (t₁/₂) in 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the blood clearance (CL) in 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the renal clearance (CL renal) in 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the terminal elimination rate constant (λz) in 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the apparent volume of distribution during terminal phase (Vz) in 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the safety of single-dose administration of DGPR1008 in patients | Vital signs examination, such as blood pressure, oxygen saturation, pulse and other data. | From the screening period to the day before withdrawal on Day 3 of the trial |
| To evaluate the pharmacokinetic characteristics of single-dose administration of DGPR1008 in patients | To measure the mean residence time (MRT₀-t, MRT₀-∞) of the drug in the blood of 24 subjects | PK blood samples will be collected 60 minutes before drug administration, and immediately, 30 minutes (±5 minutes), 1 hour (±10 minutes), 2 hours (±10 minutes), 4 hours (±20 minutes), 6 hours (±30 minutes), and 8 hours (±30 minutes) after administration. |
| To evaluate the safety of single-dose administration of DGPR1008 in patients | Physical examination, with body mass index (BMI) reported as weight (kg)/height (m²), electrocardiogram (ECG) examination, and laboratory tests (blood routine, blood biochemistry, urinalysis, coagulation function). | From the screening period to the day before withdrawal on Day 3 of the trial |
| D007263 |
| Infusions, Parenteral |