A Phase I/Ⅱa, Single-arm, Open-label Trial of DGPR1008 for Intraoperative Fluorescence Imaging of Prostate-specific Membrane Antigen-positive Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: 0.01mg/kg DGPR1008 Injection Dose Group 1 (n=6) (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.
干预措施: 0.02mg/kg DGPR1008 Injection Dose Group 2 (n=6) (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.
干预措施: Dose Group 0 (n=8) (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.
干预措施: 0.04mg/kg DGPR1008 Injection Dose Group 3 (n=6) (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.
干预措施: 0.08mg/kg DGPR1008 Injection Dose Group 4 (n=6) (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: through study completion, an average of 5 Days
Incidence of Treatment-Emergent Adverse Events
Number of participants with abnormal vital signs
时间窗: through study completion, an average of 5 Days
blood pressure in mmHg
Number pf participants with abnormal laboratory tests results
时间窗: through study completion, an average of 5 Days
urinalysis
The number of participants with abnormal BMI
时间窗: through study completion, an average of 5 Days
Weight and height will be combined to report BMI in kg/m\^2
次要结局
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
- 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.)
研究者
Haitao Niu, MD
Clinical Professor
The Affiliated Hospital of Qingdao University