A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Inclusion criteria

• ✓. Male or non- pregnant, non-lactating female aged 18 to 80;
• ✓. The patient has been on stable, adequate hemodialysis treatment for \>3 months prior to screening;
• ✓. Intact parathyroid hormone (iPTH) level of at least 300 pg/mL;
• ✓. Serum calcium (corrected serum calcium if albumin \<40 g/L) ≥2.25 mmol/L (9.0mg/dL);
• ✓. Hemoglobin ≥ 8.0 g/dL;
• ✓. Subject is clinically stable, as judged by medical history, physical examination, and routine laboratory tests, apart from chronic renal failure;
• ✓. Able to understand and willing to sign the written informed consent form;
• ✓. Women of childbearing potential must have a negative pregnancy test result prior to enrollment, or be postmenopausal for at least 1 year, or be permanently sterile(i.e., documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) for ≥6 weeks. Fertile men with partners of childbearing potential and women of childbearing potential must use effective contraception (i.e., any combination of two of the following: male or female condom with spermicidal gel,diaphragm, sponge, or cervical cap with spermicidal gel) from signing the informed consent until 90 days after MT1013 infusion.

Exclusion criteria