NCT07284043 A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
| NCT ID | NCT07284043 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Shaanxi Micot Pharmaceutical Technology Co., Ltd. |
| Condition | Hemodialysis Subjects With Secondary Hyperparathyroidism |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-11-30 |
| Primary Completion | 2026-11 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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, de