A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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;
Locations
Other Locations
China
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
RECRUITING
Jinan
Contact Information
Primary
Wei Zhao, Ph.D.
zhao4wei2@hotmail.com
0531-89268960
Backup
Yong Wei, Ph.D.
Weiyong0901@163.com
0531-89269002
Time Frame
Start Date: 2025-11-30
Estimated Completion Date: 2027-03
Participants
Target number of participants: 6
Treatments
Experimental: [14C] MT1013/MT1013 Injection Group
Related Therapeutic Areas
Sponsors
Leads: Shaanxi Micot Pharmaceutical Technology Co., Ltd.