Actively Recruiting
Efficacy and Safety of Subcutaneous Injection of XH-02 in the Treatment of Adult Hypoparathyroidism
Led by Peking Union Medical College Hospital · Updated on 2026-04-15
15
Participants Needed
1
Research Sites
32 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Subcutaneous Injection of XH-02 in the Treatment of Adult Hypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years, male or female
- History of chronic hypoparathyroidism for at least 26 weeks confirmed by low calcium and low PTH levels
- Inadequate control of hypoparathyroidism with calcium and vitamin D treatment or intolerance to such treatment
- Body Mass Index (BMI) between 17 and 40 kg/m²
- For participants aged 25 years or younger, radiographic evidence of epiphyseal closure by wrist and hand X-ray
You will not qualify if you...
- Pseudohypoparathyroidism with resistance to PTH and elevated PTH levels during low calcium
- Known allergy or history of allergy to the investigational drug or polyethylene glycol (PEG)
- Other diseases affecting calcium metabolism or PTH levels, including active hyperthyroidism, Paget's disease, severe hypomagnesemia, poorly controlled diabetes, severe liver or kidney disease, Cushing's syndrome, multiple myeloma, active pancreatitis, malnutrition, rickets, recent immobilization, active malignancy (except certain thyroid or skin cancers), active hyperparathyroidism, history of parathyroid cancer within 5 years, acromegaly, multiple endocrine neoplasia
- Vaccination within 4 weeks prior to enrollment or planned vaccination during the study
- Pregnant or breastfeeding women
- High-risk thyroid cancer requiring TSH suppression or history of malignancy
- Long-term use of certain medications including diuretics, phosphate binders (except calcium), digoxin, lithium, methotrexate, high-dose biotin, systemic corticosteroids (except replacement therapy), hormones, or immunosuppressants
- Use of PTH-like drugs within 4 weeks prior to screening
- Participation in another interventional trial within 8 weeks prior to screening or within 5.5 half-lives of prior investigational drugs
- Uncontrolled hypertension or history of specific cardiovascular or cerebrovascular diseases
- Increased risk of osteosarcoma due to certain conditions or prior radiation therapy
- Abnormal laboratory test results meeting specific blood, liver, or kidney function criteria
- Any other medical condition that could affect study conduct or increase risk as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
S
Sanxi Ai, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
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