NCT07530705

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

Efficacy and Safety of Subcutaneous Injection of mRNA Nucleic Acid Drug XH-02 in the Treatment of Adult Hypoparathyroidism

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

XH-02 is an mRNA nucleic acid drug that expresses PTH in the body following intravenous or subcutaneous injection, providing PTH replacement therapy for patients with hypoparathyroidism. Animal studies have shown pharmacodynamic effects of XH-02, with a favorable safety profile. A clinical study of intravenously administered XH-02 has been completed in patients with hypoparathyroidism, yielding clear pharmacodynamic results and demonstrating good safety. This study aims to evaluate the safety and efficacy of subcutaneously injected XH-02 in patients with hypoparathyroidism.

Conditions

• Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	Single subcutaneous injection	Participants will receive a single dose of XH-02 through subcutaneous injection.
DRUG	Multiple subcutaneous injection	Participants will receive once daily subcutaneous injection of XH-02 for 5 consecutive days.

Timeline

• Start date: 2025-11-17
• Primary completion: 2026-05-31
• Completion: 2026-06-30
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: China