Research on PSMA-Targeted Intraoperative Fluorescent Imag... | NCT07101354

NCT07101354

ID	Type	Description	Link
CXHL2400243	Other Identifier	NMPA

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Evaluation indices for pharmacokinetics(Cmax)	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))

Eligibility Module