This is a multi-center, open, single-arm phase IIb clinical study comprising 2 parts, which Part A will enroll about 110 subjects, and Part B will enroll about 190 subjects to investigate long-term efficacy and safety of MT1013 after treatment.The treatment duration for Part A MAD study is 52 weeks and the duration for Part B study is 26 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
310
MT1013 is a novel calcimimetic agent
First Affiliated Hospital College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGThe occurrence of adverse events within 26 weeks
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: Baseline up to 26 weeks
Percentage of participants with iPTH during 150-300pg/mL at week 26
Time frame: at week 26
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