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

Shaanxi Micot Pharmaceutical Technology Co., Ltd.

Status and phase

Enrolling

Phase 1

Conditions

Hemodialysis Subjects With Secondary Hyperparathyroidism

Treatments

Drug: [14C] MT1013/MT1013 Injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT07284043

MT1013-I-C03

Details and patient eligibility

About

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.

Enrollment

6 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.