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RECRUITING
NCT07530705
PHASE1/PHASE2

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-11-17

Completion Date

2026-06-30

Last Updated

2026-04-15

Healthy Volunteers

No

Interventions

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China