An Expanded Cohort Study on the Safety and Efficacy of mRNA Nucleic Acid Drug XH-02 in Treating Adult Hypoparathyroidism
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. Previous clinical studies have demonstrated the safety of subcutaneously administered XH-02 in several patients with hypoparathyroidism and have yielded clear efficacy results. This study aims to further validate the safety and efficacy of subcutaneously injected XH-02 in the treatment of hypoparathyroidism in a expanded cohort.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:
• Age ≥18 years, both males and females eligible;
• History of postoperative chronic HP or autoimmune, genetic, or idiopathic HP for at least 26 weeks. The diagnosis of HP is established based on the presence of inappropriately low serum PTH levels concurrent with hypocalcemia in the past.
• Poorly controlled or intolerant to conventional treatment (calcium and vitamin D) for hypoparathyroidism;
• BMI 17-40 kg/m² (inclusive) at screening;
• If age ≤25 years, radiographic evidence of epiphyseal closure based on X-ray results of the wrist and palm of the non-dominant hand.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
SanXi Ai, Doctor
sanxiai@163.com
18811054896
Time Frame
Start Date:2026-04-13
Estimated Completion Date:2030-07-30
Participants
Target number of participants:60
Treatments
Experimental: Single dose: 40 μg
Participants will receive a single subcutaneous dose of 40 μg of XH-02
Experimental: Single dose: 60 μg
Participants will receive a single subcutaneous dose of 60 μg of XH-02
Experimental: Single dose: 80 μg
Participants will receive a single subcutaneous dose of 80 μg of XH-02
Experimental: Single dose: 120 μg
Participants will receive a single subcutaneous dose of 120 μg of XH-02
Experimental: Single dose: 160 μg
Participants will receive a single subcutaneous dose of 160 μg of XH-02
Experimental: Multiple dose: 40 μg
Participants will receive 40 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Experimental: Multiple dose: 60 μg
Participants will receive 60 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Experimental: Multiple dose: 80 μg
Participants will receive 80 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Experimental: Multiple dose: 120 μg
Participants will receive 120 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Experimental: Multiple dose: 160 μg
Participants will receive 160 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.