NCT07057414招募中2 期
Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study to Evaluate the Safety and Efficacy of GMDTC for Injection in Subjects With Elevated Cadmium Levels
Guangdong Jianersheng Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年7月7日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Pharmacodynamic Parameters , 24-hour urinary cadmium
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, single-center Phase IIa clinical study.
详细描述
The primary objective of this study is to evaluate the pharmacodynamic characteristics of GMDTC for Injection in subjects with elevated cadmium levels after administration, while the secondary objectives are to assess the safety, tolerability and pharmacokinetic profile of GMDTC for Injection following multiple-dose administration in the same population; based on the results from Phase I single- and multiple-dose studies, the initial dose group in this trial is set at 2000 mg with a concentration of 4 mg/mL, where the first 4 participants (including 3 in the treatment group and 1 in the placebo group) will be enrolled first, and subsequent participants in the same dose group can only continue enrollment after investigators complete the 72-hour post-dose safety and tolerability assessments and confirm favorable results, with the SMC meeting to determine subsequent study plans including but not limited to dose escalation, concentration adjustment or increased treatment duration after completion of observation for each dose group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participants must meet all of the following criteria to be enrolled in this trial:
- •Voluntarily sign the informed consent form, aged between 18 and 70 years (inclusive), regardless of gender;
- •Single morning urine cadmium >5 μg/g creatinine (with creatinine concentration ≥0.3 g/L and ≤3 g/L);
- •eGFR ≥30 mL/min/1.73 m² (calculated using the CKD-EPI formula).
排除标准
- •Participants who meet any of the following criteria will be excluded from this study:
- •Currently suffering from any clinically significant disease that, in the investigator's judgment, poses a safety risk for participation in this clinical trial;
- •Patients with a history of kidney disease requiring hemodialysis;
- •Patients with a history of severe infusion-related allergic reactions, known allergies to three or more substances, or known hypersensitivity to any component of this product (e.g., disodium edetate, mannitol);
- •Previous diagnosis of diabetes with poorly controlled blood glucose;
- •History of conditions predisposing to hypokalemia (e.g., periodic hypokalemia, primary aldosteronism);
- •High-risk uncontrolled arrhythmia within the past 6 months, including:
- •1) Resting atrial tachycardia with heart rate >100 bpm, 2) Significant ventricular arrhythmia (e.g., ventricular tachycardia), 3) High-grade atrioventricular block (e.g., Mobitz type II second-degree or third-degree AV block), 4) NYHA Class IV heart failure, 5) Left ventricular ejection fraction (LVEF) <50%; 7.Prolonged QT/QTc interval at screening/baseline (QTc: >450 ms in males, >470 ms in females) or known family history of long QT syndrome;
- •Use of any medication or supplement (e.g., SGLT2 inhibitors like dapagliflozin, canagliflozin, empagliflozin, etc.; GLUT2 inhibitors like cytochalasin B, phloretin, etc.) within 14 days prior to screening that may interact with the investigational drug;
- •Participation in any other clinical trial involving investigational drugs or medical devices within 3 months prior to screening;
- •Major surgery within 4 weeks before screening or planned surgery during the trial that may affect drug metabolism or safety assessment;
- •Blood donation or significant blood loss (≥200 mL, excluding menstrual bleeding), transfusion, or use of blood products within 1 month prior to screening;
- •Intolerance to venipuncture and/or history of syncope due to blood or needle exposure;
- •Pregnant or lactating women, or participants unwilling to use effective non-pharmacological contraception during the trial;
- •Inability to use contraception for 6 months after trial completion; 15.Inability to comply with dietary restrictions or nutritional guidelines; 16.Alcohol abuse or regular alcohol consumption (>14 units/week; 1 unit ≈ 200 mL beer [5%], 25 mL spirits [40%], or 85 mL wine [12%]) within 6 months before screening, or unwillingness to abstain from alcohol during the trial;
- •Participants with unstable psychiatric disorders, in the investigator's opinion, who cannot cooperate with the study;
- •Any other condition deemed by the investigator to compromise study compliance or safety.
研究组 & 干预措施
GMDTC Group
Experimental
Participants randomized to the GMDTC Group will receive daily administrations (GMDTC for Injection ) after breakfast from Day 1 to Day 5 and Day 8 to Day 12.
干预措施: GMDTC for injection (Drug)
Placebo Group
Placebo Comparator
Participants randomized to the Placebo Group will receive daily administrations (normal saline for Injection ) after breakfast from Day 1 to Day 5 and Day 8 to Day 12.
干预措施: 0.9% Sodium Chloride Injection(0.9% NaCl) (Other)
结局指标
主要结局
Pharmacodynamic Parameters , 24-hour urinary cadmium
时间窗: Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13)
24-hour urinary cadmium excretion before and after drug administration(μg/L)
次要结局
- Adverse Events (AEs)(Within 30 days after the last dose administration)
- Pharmacodynamic Parameters , Urinary Cadmium and Lead Levels(Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15))
- Pharmacodynamic Parameters , 24-Hour Urinary Lead and Copper(Evaluated at pre-dose (Day-1) and post-dose (Day1-Day6, Day8-Day13))
- Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Pb, As, Hg, Cr, Mn)(Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13))
- Pharmacodynamic Parameters , Blood Heavy Metal/Metalloid Levels(Cu, Zn)(Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13))
- Pharmacodynamic Parameters , Renal Function Biomarker Levels(Creatinine-corrected urinary β2-MG, Creatinine-corrected urinary URBP)(Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15))
- Pharmacodynamic Parameters , Renal Function Biomarker Levels(β2-MG, URBP)(Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15))
- Pharmacodynamic Parameters , Renal Function Biomarker Levels(α1-MG)(Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15))
- Pharmacodynamic Parameters , Renal Function Biomarker Levels(NAG)(Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13, Day15))
- Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(PTH)(Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13))
- Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(25(OH)D, P1NP, CTX)(Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13))
- Pharmacodynamic Parameters, Bone Metabolism Biomarker Levels(ALP)(Evaluated at Pre-dose (Screening Period) and post-dose (Day6, Day13))
- Pharmacodynamic Parameters , urinary cadmium Levels(Evaluated from Baseline (Pre-dose Day1) to First Void Post-dose (Day1-Day5 & Day8-Day12))
- Pharmacodynamic Parameters , Blood Cadmium Concentration(Evaluated at pre-dose (Day1) and post-dose (Day6, Day8, Day13))
- Pharmacokinetic Parameters , Tmax(Evaluated at baseline, during drug infusion, and within 24 hours after drug administration)
- Pharmacokinetic Parameters , Cmax(Evaluated at baseline, during drug infusion, and within 24 hours after drug administration)
- Pharmacokinetic Parameters , λz(Evaluated at baseline, during drug infusion, and within 24 hours after drug administration)
- Pharmacokinetic Parameters , t1/2(Evaluated at baseline, during drug infusion, and within 24 hours after drug administration)
研究者
研究点 (1)
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