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

NCT07284043 | Recruiting Phase 1

• 1 other identifier: MT1013-I-C03
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis Subjects With Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Adverse Events (AEs)

  About 13 weeks.

• Serious adverse Events (SAEs)

  About 13 weeks.

Study Arms (1)

[14C] MT1013/MT1013 Injection Group

EXPERIMENTAL

Drug: [14C] MT1013/MT1013 Injection

Interventions

[14C] MT1013/MT1013 Injection DRUG

\[14C\] MT1013/MT1013 Injection

[14C] MT1013/MT1013 Injection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or postmenopausal female participants, aged 18 years or older, with a confirmed diagnosis of SHPT.
• \. The BMI is between 18 kg/m2 and 35 kg/m2;
• \. The subjects must undergo regular maintenance hemodialysis three times a week for at least three months；
• \. Within 14 days prior to randomization, subjects must have serum calcium levels≥ 8.4 mg/dL;
• Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;

You may not qualify if:

• \. The subjects underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
• \. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
• \. The subjects had myocardial infarction or had undergone coronary angioplasty or coronary artery bypass grafting within 6 months before screening.
• ．Subjects with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg;
• \. History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
• \. History of malignant tumors within the five years prior to screening;
• \. The subjects received oral cinacalcet or ivocalcet within 7 days before signing the informed consent form, or received Etelcalcetide injection treatment within 4 months.
• \. 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;
• \. Participants who may not be able to complete this study for other reasons or who the researchers consider should not be included.

Sponsors & Collaborators

• Shaanxi Micot Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

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

Jinan, Shandong, 250014, China

RECRUITING

Central Study Contacts

Wei Zhao, Ph.D.

CONTACT

0531-89268960; zhao4wei2@hotmail.com

Yong Wei, Ph.D.

CONTACT

0531-89269002; Weiyong0901@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 16, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

CN (1)