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

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.

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.