Efficacy and Safety of mRNA Drug XH02 in the Treatment of Adult Hypoparathyroidism

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This study aims to evaluate the safety and efficacy of a novel PTH replacement therapy drug in patients with hypoparathyroidism. The drug is an mRNA drug which will be translated into PTH after intravenous administration, to achieve the therapeutic effect.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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• Age 18 to 65 years (inclusive), male or female.

• Documented history of post-surgical chronic HP or autoimmune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is confirmed based on a history of hypocalcemia accompanied by an inappropriately low serum PTH level (below the upper limit of the normal range of the local laboratory). \* Note: If a subject lacks documented diagnosis of chronic HP but has exhibited hypocalcemia accompanied by an inappropriately low serum PTH level for at least 26 weeks prior to screening, and is judged by the investigator to meet the diagnostic criteria for chronic HP, they will be considered eligible for this criterion.

• Poorly controlled or intolerant to conventional therapy (calcium and active vitamin D).

• Conventional therapy (including vitamin D or magnesium supplements, if applicable) can be optimized during the screening period to achieve the following target serum levels: 25(OH) Vitamin D level: 10 - 100 ng/mL (25 - 250 nmol/L, inclusive). Blood magnesium level: Within the normal range or slightly below, i.e., ≥ 1.3 mg/dL (≥ 0.53 mmol/L). Albumin-corrected serum calcium (sCa) level: Within the normal range or slightly below

• Body Mass Index (BMI) of 17 to 40 kg/m² (inclusive) at screening.

• If aged ≤ 25 years, radiological evidence of closed epiphyses based on X-ray of the non-dominant hand (wrist and palm).

Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 6
Treatments
Experimental: 20ug
PTH1-84 mRNA 20ug
Experimental: 40ug
PTH1-84 mRNA 40ug
Experimental: 80ug
PTH1-84 mRNA 80ug
Experimental: 120ug
PTH1-84 mRNA 120ug
Experimental: 160ug
PTH1-84 mRNA 160ug
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital

This content was sourced from clinicaltrials.gov

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