RecruitingPhase 1NCT07284043

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

Sponsor

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Enrollment

6 participants

Start Date

Nov 30, 2025

Study Type

INTERVENTIONAL

Conditions

Hemodialysis Subjects With Secondary Hyperparathyroidism

Summary

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

Min Age: 18 Years

Inclusion Criteria5

\. Male or postmenopausal female participants, aged 18 years or older, with a confirmed diagnosis of SHPT.
\. The BMI is between 18 kg/m2 and 35 kg/m2;
\. The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
\. Within 14 days prior to randomization, subjects must have serum calcium levels≥ 8.4 mg/dL;
Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;

Exclusion Criteria9

\. The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
\. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
\. The subjects had myocardial infarction or had undergone coronary angioplasty or coronary artery bypass grafting within 6 months before screening.
．Subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg;
\. History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
\. History of malignant tumors within the five years prior to screening;
\. The subjects received oral cinacalcet or ivocalcet within 7 days before signing the informed consent form, or received Etelcalcetide injection treatment within 4 months.
\. 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;
\. Participants who may not be able to complete this study for other reasons or who the researchers consider should not be included.

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Interventions

DRUG[14C] MT1013/MT1013 Injection

\[14C\] MT1013/MT1013 Injection

Locations(1)

The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)

Jinan, Shandong, China

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NCT07284043