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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Subjects With Secondary Hyperparathyroidism
• Intervention / Treatment: Drug: [14C] MT1013/MT1013 Injection

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Zhao, Ph.D.; Phone Number: 0531-89268960; Email: zhao4wei2@hotmail.com
• Study Contact Backup: Name: Yong Wei, Ph.D.; Phone Number: 0531-89269002; Email: Weiyong0901@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
      • Contact: Wei Zhao, Ph.D.; Phone Number: 0531-89268960; Email: zhao4wei2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C] MT1013/MT1013 Injection Group	Drug: [14C] MT1013/MT1013 Injection; [14C] MT1013/MT1013 Injection

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
Adverse Events (AEs)	About 13 weeks.
Serious adverse Events (SAEs)	About 13 weeks.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: MT1013-I-C03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No