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A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism

A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Recruiting
18 years and older
All
Phase 1

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Overview

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.

Eligibility

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Study details
    Hemodialysis Subjects With Secondary Hyperparathyroidism

NCT07284043

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

1 February 2026

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