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

April 8, 2026 updated by: Yan Qin, Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Yan Qin, Doctor
        • Principal Investigator:
          • Ou Wang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18-65 years (inclusive of 18 and 65), male or female.
  2. A history of postoperative chronic hypoparathyroidism (HP) or autoimmune, genetic, or idiopathic HP for at least 26 weeks. HP is confirmed based on a previous occurrence of hypocalcemia accompanied by an inappropriately low serum parathyroid hormone (PTH) level (below the upper limit of the local laboratory's normal range). Note: If the subject does not have a documented diagnosis of chronic HP but has experienced hypocalcemia accompanied by an inappropriately low serum PTH level for at least 26 weeks prior to screening, and the investigator determines that the diagnosis of chronic HP is met, this criterion is considered fulfilled.
  3. Inadequate control of hypoparathyroidism with conventional treatment (calcium and vitamin D) or intolerance to such treatment.
  4. At screening, Body Mass Index (BMI) of 17-40 kg/m² (inclusive).
  5. If aged ≤25 years, radiographic evidence of epiphyseal closure based on X-ray examination of the wrist and hand of the non-dominant hand.

Exclusion Criteria:

  1. Impaired response to PTH (pseudohypoparathyroidism), characterized by resistance to PTH and elevated PTH levels during hypocalcemia.
  2. Known allergies, or a history of allergy to the investigational drug or polyethylene glycol (PEG).
  3. Any disease other than HP that may affect calcium metabolism, calcium-phosphorus homeostasis, or PTH levels, such as active hyperthyroidism; Paget's disease of bone; severe hypomagnesemia; Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus (HbA1C >9%, HbA1C test results from blood samples collected within 12 weeks prior to screening are acceptable); severe and chronic liver or kidney disease; Cushing's syndrome; multiple myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobilization; active malignancy (except for low-risk well-differentiated thyroid cancer or non-melanoma skin cancer); active hyperparathyroidism; history of parathyroid cancer within 5 years prior to screening; acromegaly; or multiple endocrine neoplasia.
  4. History of vaccination within 4 weeks prior to enrollment, or planned vaccination during the study period.
  5. Women who are pregnant or breastfeeding.
  6. Patients with high-risk thyroid cancer requiring TSH suppression to <0.2 mIU/L within the past 2 years, or those with a history of malignancy.
  7. Subjects requiring long-term use of diuretics, phosphate binders (except calcium supplements), digoxin, lithium, methotrexate, biotin >30 μg/day, or systemic corticosteroids (except as replacement therapy). Patients requiring long-term use of hormones or immunosuppressants (e.g., for rheumatic or autoimmune diseases) will not be enrolled in this study. Note: Subjects who can discontinue these medications during the study may be enrolled, but they must be discontinued for at least 5.5 half-lives prior to Visit 1 blood sample collection. Biotin must be discontinued for at least 1 day prior to screening blood sample collection. These medications are prohibited throughout the study.
  8. Use of PTH-like drugs (either commercially available or obtained through participation in a clinical trial), including PTH (1-84), PTH (1-34), or other N-terminal fragments or analogs of PTH, or PTH-related protein, within 4 weeks prior to screening.
  9. Participation in any other interventional trial and receipt of investigational drug or device within 8 weeks prior to screening, or still within 5.5 half-lives of the drug from a previously participated trial.
  10. Presence of uncontrolled hypertension at baseline, or a history of the following cardiovascular or cerebrovascular diseases, including: (1) Unstable angina; (2) Arrhythmia requiring medication or severe arrhythmia; (3) Myocardial infarction; (4) Class III or higher heart failure (per NYHA classification), second-degree or higher atrioventricular block; (5) Cerebral infarction (except lacunar infarction), cerebral hemorrhage, or other such conditions.
  11. Increased risk of osteosarcoma, for example, having Paget's disease of bone or unexplained elevated alkaline phosphatase, genetic disorders predisposing to osteosarcoma, or previous exposure to high-dose external beam radiation or implant radiotherapy to the skeleton.
  12. Abnormal laboratory test results meeting any of the following criteria: Blood routine: Neutrophil count (NEUT#) <1.5×10⁹/L; Platelet count (PLT) <90×10⁹/L; Hemoglobin (Hb) <90g/L; Eosinophil count (EOS#) >0.5×10⁹/L. Liver and kidney function: Total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the normal range; eGFR <60 ml/min/1.73m².
  13. Any other medical or other condition that, in the investigator's judgment, might affect the conduct of the study or interfere with the study results, or might increase the risk to the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single dose (40 μg)
Participants will receive a single subcutaneous dose of 40 μg of XH-02
Drug: Single subcutaneous injection
Participants will receive a single dose of XH-02 through subcutaneous injection.
Experimental: Single dose (80 μg)
Participants will receive a single subcutaneous dose of 80 μg of XH-02
Drug: Single subcutaneous injection
Participants will receive a single dose of XH-02 through subcutaneous injection.
Experimental: Single dose (120 μg)
Participants will receive a single subcutaneous dose of 120 μg of XH-02
Drug: Single subcutaneous injection
Participants will receive a single dose of XH-02 through subcutaneous injection.
Experimental: Multiple doses (20 µg）
Participants will receive a daily subcutaneous injection of 20 µg of XH-02 for 5 consecutive days
Drug: Multiple subcutaneous injection
Participants will receive once daily subcutaneous injection of XH-02 for 5 consecutive days.
Experimental: Multiple doses (40 µg）
Participants will receive a daily subcutaneous injection of 40 µg of XH-02 for 5 consecutive days
Drug: Multiple subcutaneous injection
Participants will receive once daily subcutaneous injection of XH-02 for 5 consecutive days.
Experimental: Multiple doses (60 µg）
Participants will receive a daily subcutaneous injection of 60 µg of XH-02 for 5 consecutive days
Drug: Multiple subcutaneous injection
Participants will receive once daily subcutaneous injection of XH-02 for 5 consecutive days.
Experimental: Multiple doses (80 µg）
Participants will receive a daily subcutaneous injection of 80 µg of XH-02 for 5 consecutive days
Drug: Multiple subcutaneous injection
Participants will receive once daily subcutaneous injection of XH-02 for 5 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (safety)
Time Frame: From the first dose through 30 days after the last dose for non-serious adverse events, and through 3 months after the last dose for severe adverse events.

Adverse events, including serious adverse events.

Assessment methods:

spontaneous reports; scheduled laboratory tests (hematology, chemistry, C-reactive protein, urinalysis); vital signs (blood pressure, heart rate, respiratory rate, temparature), physical examinations, and electrocardiogram (QTc interval, arrhythmia).
From the first dose through 30 days after the last dose for non-serious adverse events, and through 3 months after the last dose for severe adverse events.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTH(1-84) (efficacy)
Time Frame: Single dose: Predose (within one hour before administration), and 4, 8, 12, 18, 24, 30, 36, 48, 60, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 4, 8, 12, 24, 30, 36, 48, 60, and 72 hours after the last dose.
serum PTH(1-84)
Single dose: Predose (within one hour before administration), and 4, 8, 12, 18, 24, 30, 36, 48, 60, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 4, 8, 12, 24, 30, 36, 48, 60, and 72 hours after the last dose.
PTH (efficacy)
Time Frame: Single dose: Predose (within one hour before administration), and 4, 8, 12, 18, 24, 30, 36, 48, 60, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 4, 8, 12, 24, 30, 36, 48, 60, and 72 hours after the last dose
serum PTH
Single dose: Predose (within one hour before administration), and 4, 8, 12, 18, 24, 30, 36, 48, 60, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 4, 8, 12, 24, 30, 36, 48, 60, and 72 hours after the last dose
Serum calcium (efficacy)
Time Frame: Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum calcium
Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum phosphorus (efficacy)
Time Frame: Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum phosphorus
Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum magnesium (efficacy)
Time Frame: Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum magnesium
Single dose: Predose (within one hour before administration), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
1, 25-Dihydroxyvitamin D3 (efficacy)
Time Frame: Single dose: Predose (within one hour before administration); and 24, 48, and 72 hours postdose. Multiple dose: Predose on Day 1, Day 3, Day 5; and 48 hours and 72 hours after the last dose.
Serum 1, 25-Dihydroxyvitamin D3
Single dose: Predose (within one hour before administration); and 24, 48, and 72 hours postdose. Multiple dose: Predose on Day 1, Day 3, Day 5; and 48 hours and 72 hours after the last dose.
24-hour urine calcium (efficacy)
Time Frame: Single dose: Predose (within 3 days before administration), and 24, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose), and 24, 48, and 72 hours after the last dose
24-hour urine calcium (24hUCa)
Single dose: Predose (within 3 days before administration), and 24, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose), and 24, 48, and 72 hours after the last dose
Fractional Excretion of calcium (efficacy)
Time Frame: Single dose: Predose (within one hour before administration), and 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose), and 24, 48, and 72 hours after the last dose
Fractional Excretion of calcium (FECa)
Single dose: Predose (within one hour before administration), and 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose on Day 1 to 5 (before each dose), and 24, 48, and 72 hours after the last dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procollagen type 1 N-terminal propeptide (Exploratory endpoint)
Time Frame: Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum Procollagen type 1 N-terminal propeptide (P1NP)
Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Beta-isomerized C-terminal telopeptide of type 1 collagen (Exploratory endpoint)
Time Frame: Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose
Serum Beta-isomerized C-terminal telopeptide of type 1 collagen (β-CTX)
Multiple dose: Predose on Day 1 to 5 (before each dose); and 24, 48, and 72 hours after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Yan Qin, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2025

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K9040

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not plan to share Individual Participant Data (IPD) due to confidentiality agreements and participant privacy commitments.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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