Study to Confirm Safety and Effectiveness of mRNA Drug XH-02 for Adults With Hypoparathyroidism

What this Trial Is About

Researchers are evaluating the safety and effectiveness of XH-02, an mRNA nucleic acid drug that produces parathyroid hormone PTH in the body, to treat adults with hypoparathyroidism. This condition involves low PTH levels leading to low calcium in the blood. Previous studies have shown that subcutaneous injection of XH-02 is safe and effective, and this expanded phase 2 study aims to confirm these findings in a larger group of patients. Participants will receive different doses of XH-02 by subcutaneous injection. Some will get a single dose ranging from 40 to 160 micrograms, while others will receive multiple doses of 40 to 160 micrograms daily or every other day for a total of five doses. The study includes several groups receiving these different dosing regimens to assess safety and treatment response. Throughout the study, participants will undergo various blood and urine tests to measure PTH levels, calcium, phosphorus, magnesium, vitamin D, and other markers. Safety is monitored by recording adverse events from the first dose up to 30 days for non-serious events and 3 months for serious events. The study will follow participants for these assessments to evaluate both safety and how well the drug works over time.

A Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism