Safety and Effectiveness of Subcutaneous XH-02 Injections for Treating Adult Hypoparathyroidism

What this Trial Is About

Researchers are investigating the safety and effectiveness of a new mRNA-based drug called XH-02 for adults with hypoparathyroidism, a condition where the body does not produce enough parathyroid hormone PTH. Previous animal studies and an intravenous clinical trial showed promising results with favorable safety. This study focuses on evaluating XH-02 when given by subcutaneous injection to provide PTH replacement therapy for patients whose condition is not well controlled by conventional treatments. Participants will receive different doses of XH-02 through subcutaneous injections. Some will get a single dose of 40, 80, or 120 micrograms, while others will receive daily injections of 20, 40, 60, or 80 micrograms for five consecutive days. The study is non-randomized and open-label, meaning all participants know the treatment they receive. The trial is sponsored by Peking Union Medical College Hospital and includes both Phase 1 and Phase 2 stages. During the study, participants will be monitored for adverse events from the first dose through 30 days after the last dose for mild events, and up to three months for more serious events. Researchers will measure hormone levels including PTH, calcium, phosphorus, magnesium, and vitamin D metabolites at multiple time points before and after dosing. Urine calcium and calcium excretion will also be assessed. These evaluations will help determine the drugs effects and safety over the study period, which runs until June 2026.

Efficacy and Safety of Subcutaneous Injection of XH-02 in the Treatment of Adult Hypoparathyroidism