Actively Recruiting
Study to Confirm Safety and Effectiveness of mRNA Drug XH-02 for Adults With Hypoparathyroidism
Led by Peking Union Medical College Hospital · Updated on 2026-05-18
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of XH-02, an mRNA nucleic acid drug that produces parathyroid hormone PTH in the body, to treat adults with hypoparathyroidism. This condition involves low PTH levels leading to low calcium in the blood. Previous studies have shown that subcutaneous injection of XH-02 is safe and effective, and this expanded phase 2 study aims to confirm these findings in a larger group of patients. Participants will receive different doses of XH-02 by subcutaneous injection. Some will get a single dose ranging from 40 to 160 micrograms, while others will receive multiple doses of 40 to 160 micrograms daily or every other day for a total of five doses. The study includes several groups receiving these different dosing regimens to assess safety and treatment response. Throughout the study, participants will undergo various blood and urine tests to measure PTH levels, calcium, phosphorus, magnesium, vitamin D, and other markers. Safety is monitored by recording adverse events from the first dose up to 30 days for non-serious events and 3 months for serious events. The study will follow participants for these assessments to evaluate both safety and how well the drug works over time.
CONDITIONS
Brief Title
A Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, males and females eligible
- History of postoperative chronic hypoparathyroidism or autoimmune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks
- Diagnosis confirmed by low serum PTH levels with hypocalcemia
- Poorly controlled or intolerant to conventional calcium and vitamin D treatment
- Body mass index between 17 and 40 kg/m² at screening
- For participants 25 years or younger, radiographic evidence of epiphyseal closure is required
You will not qualify if you...
- Pseudohypoparathyroidism with PTH resistance and elevated PTH levels
- Allergy to the investigational drug or polyethylene glycol (PEG)-based drugs
- Diseases affecting calcium metabolism or PTH levels, including active hyperthyroidism, Paget's disease, severe hypomagnesemia, diabetes with poor control, severe liver/kidney disease, Cushing's syndrome, multiple myeloma, active pancreatitis, malnutrition, rickets, recent immobilization, active malignancy except low-risk thyroid or skin cancer, active hyperparathyroidism, parathyroid carcinoma within 5 years, acromegaly, or multiple endocrine neoplasia
- Pregnant or breastfeeding women
- Male partners of women planning pregnancy or partners unwilling to use contraception
- High-risk thyroid cancer needing TSH suppression or history of tumors
- Use of certain medications including loop diuretics, phosphate binders (except calcium), digoxin, lithium, methotrexate, high-dose biotin, or systemic corticosteroids except replacement therapy
- Use of PTH-like drugs within 4 weeks prior to screening
- Participation in other interventional trials with investigational drugs/devices within 8 weeks prior
- Uncontrolled hypertension or serious cardiovascular/cerebrovascular diseases
- Increased risk of osteosarcoma due to conditions or prior radiation
- Diseases causing poor gastrointestinal absorption
- Any condition that may affect study conduct or increase risk according to investigator judgment
Research Team
S
SanXi Ai, Doctor
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