Prostate CA, Prostate Cancer Patients Undergoing Radical Prostatectomy
Conditions
Brief 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) of DGPR1008.
Interventions
DRUG0.08mg/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.
DRUG0.01mg/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.
DRUG0.02mg/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.
DRUG0.04mg/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.
DRUGDose 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.
Sponsors
Haitao Niu, MD
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | through study completion, an average of 5 Days | Incidence of Treatment-Emergent Adverse Events |
| Number of participants with abnormal vital signs | through study completion, an average of 5 Days | temperature in ℃ |
| The number of participants with abnormal BMI | 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 | through study completion, an average of 5 Days | complete blood count |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation indices for pharmacokinetics(t1/2) | 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 |
| Evaluation indices for pharmacokinetics(CL) | 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 |
| Evaluation indices for pharmacokinetics(CLRenal) | 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 |
| Evaluation indices for pharmacokinetics(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. | Cmax |
| Evaluation indices for pharmacokinetics(Vz) | 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 |
| Evaluation indices for pharmacokinetics（MRT(0-t)、MRT(0-∞)） | 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-∞)） |
| Evaluation indices for pharmacokinetics | 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 |
| Evaluation indices for pharmacokinetics(AUC(0-t)) | 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) |
| Evaluation indices for pharmacokinetics(AUC(0-∞)) | 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-∞) |
| Evaluation indices for pharmacokinetics(AUC_%Extrap) | 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 |
Countries
China
Outcome results
None listed