The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
NCT Number: NCT07101354
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.
Looking for future studies?
Notify Me18 year–65 year
Male
Interventional
Phase 1
Qingdao, Shandong, 266000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be excluded if any of the following apply:
Within the specified time period, conduct dose escalation, and administer the corresponding dose via intravenous drip according to the randomization information.
Other names: 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.
Other names: 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.
Other names: 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.
Other names: DGPR1008, 0.08mg/kg Dose Group 4 (n=6), Treatment 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.
Other names: placebo control group
Time frame: through study completion, an average of 5 Days
Incidence of Treatment-Emergent Adverse Events
Time frame: through study completion, an average of 5 Days
temperature in ℃
Time frame: through study completion, an average of 5 Days
pulse in beats/minute
Time frame: through study completion, an average of 5 Days
blood pressure in mmHg
Time frame: through study completion, an average of 5 Days
Weight and height will be combined to report BMI in kg/m^2
Time frame: through study completion, an average of 5 Days
complete blood count
Time frame: through study completion, an average of 5 Days
blood chemistry panel
Time frame: through study completion, an average of 5 Days
urinalysis
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.
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.
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.
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.
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.
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.
CL
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.
CLRenal
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.
λz
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.
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.
(MRT(0-t)、MRT(0-∞))
Haitao Niu, MD
Other
A Phase I/Ⅱa, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer
Acronym: DGPR1008
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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