NCT07284043已完成1 期
A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Shaanxi Micot Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年11月27日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Cumulative excretion of radioactivity
研究概览
简要总结
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] MT1013.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male or postmenopausal female participants, aged 18 years or older, with a confirmed diagnosis of SHPT.
- •2. The BMI is between 18 kg/m2 and 35 kg/m2;
- •3. The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
- •4. Within 14 days prior to randomization, subjects must have serum calcium levels≥ 8.4 mg/dL;
- •5.Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
排除标准
- •1. The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
- •2. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- •3. The subjects had myocardial infarction or had undergone coronary angioplasty or coronary artery bypass grafting within 6 months before screening.
- •4．Subjects with severe uncontrolled hypertension, defined as systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg;
- •5. History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
- •6. History of malignant tumors within the five years prior to screening;
- •7. The subjects received oral cinacalcet or ivocalcet within 7 days before signing the informed consent form, or received Etelcalcetide injection treatment within 4 months.
- •8. Engaged in work that requires long-term exposure to radioactive conditions; Or those who have had significant radioactive exposure or participated in radioactive drug labeling tests within one year prior to screening;
- •9. Participants who may not be able to complete this study for other reasons or who the researchers consider should not be included.
研究组 & 干预措施
[14C] MT1013/MT1013 Injection Group
Experimental
干预措施: [14C] MT1013/MT1013 Injection (Drug)
结局指标
主要结局
Cumulative excretion of radioactivity
时间窗: Day 1 to Day 91.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
时间窗: Day 1 to Day 91.
次要结局
- Adverse Events (AEs)(About 13 weeks.)
- Serious adverse Events (SAEs)(About 13 weeks.)
研究者
研究点 (1)
Loading locations...
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