Hemodialysis Subjects With Secondary Hyperparathyroidism
Conditions
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.
Interventions
DRUG[14C] MT1013/MT1013 Injection
\[14C\] MT1013/MT1013 Injection
Sponsors
Shaanxi Micot Pharmaceutical Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative excretion of radioactivity | Day 1 to Day 91. |
| Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC) | Day 1 to Day 91. |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events (AEs) | About 13 weeks. |
| Serious adverse Events (SAEs) | About 13 weeks. |
Countries
China
Outcome results
None listed