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

NCT ID: NCT07284043

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemodialysis Subjects With Secondary Hyperparathyroidism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[14C] MT1013/MT1013 Injection Group

Group Type EXPERIMENTAL

[14C] MT1013/MT1013 Injection

Intervention Type DRUG

\[14C\] MT1013/MT1013 Injection

Interventions

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[14C] MT1013/MT1013 Injection

\[14C\] MT1013/MT1013 Injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaanxi Micot Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wei Zhao, Ph.D.

Role: CONTACT

[email protected]
0531-89268960

Yong Wei, Ph.D.

Role: CONTACT

[email protected]
0531-89269002

Facility Contacts

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Wei Zhao, Ph.D.

Role: primary

[email protected]
0531-89268960

Other Identifiers

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MT1013-I-C03

Identifier Type: -

Identifier Source: org_study_id