A Phase 2 interventional study of Single subcutaneous injection and Multiple subcutaneous injection in Hypoparathyroidism, sponsored by Peking Union Medical College Hospital. Suspended at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment
Enrollment temporarily suspended in accordance with a newly implemented regulation, State Council Decree No. 818, on clinical research and clinical translation of new biomedical technologies; pending review and approval.
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.
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 77 interventional studies indexed under Hypoparathyroidism.
Browse Hypoparathyroidism studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single subcutaneous dose of 40 μg of XH-02
Drug: Single subcutaneous injection
Participants will receive a single subcutaneous dose of 60 μg of XH-02
Drug: Single subcutaneous injection
Participants will receive a single subcutaneous dose of 80 μg of XH-02
Drug: Single subcutaneous injection
Participants will receive a single subcutaneous dose of 120 μg of XH-02
Drug: Single subcutaneous injection
Participants will receive a single subcutaneous dose of 160 μg of XH-02
Drug: Single subcutaneous injection
Participants will receive 40 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Drug: Multiple subcutaneous injection
Participants will receive 60 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Drug: Multiple subcutaneous injection
Participants will receive 80 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Drug: Multiple subcutaneous injection
Participants will receive 120 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Drug: Multiple subcutaneous injection
Participants will receive 160 μg of XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Drug: Multiple subcutaneous injection
Participants will receive a single dose of XH-02 through subcutaneous injection.
Participants will receive XH-02 via subcutaneous injection daily or every other day, for a total of 5 doses.
Adverse events (safety)
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).
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.
PTH(1-84) (efficacy)
Serum PTH(1-84)
Time frame: Single dose: Predose (within one hour before dosing) and 4, 8, 12, 18, 24, 30, 36, 48, 60, and 72 hours postdose. Multiple dose: Predose (within one hour before each dose) and 4, 8, 12, 24, 30, 36, 48, 60, and 72 hours after the last dose.
PTH (efficacy)
Serum PTH
Time frame: Single dose: Predose (within one hour before dosing) and 4, 8, 12, 18, 24, 30, 36, 48, 60, and 72 hours postdose.
Serum calcium (efficacy)
Serum calcium
Time frame: Single dose: Predose (within one hour before dosing), and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose (within one hour before each dose) and 24, 48, and 72 hours after the last dose.
Serum phosphorus (efficacy)
Serum phosphorus
Time frame: Single dose: Predose (within one hour before dosing) and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose (within one hour before each dose) and 24, 48, and 72 hours after the last dose.
Serum magnesium (efficacy)
Serum magnesium
Time frame: Single dose: Predose (within one hour before dosing) and 4, 8, 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose (within one hour before each dose) and 24, 48, and 72 hours after the last dose.
1, 25-Dihydroxyvitamin D3 (efficacy)
Serum 1, 25-Dihydroxyvitamin D3
Time frame: Single dose: Predose (within one hour before dosing) and 24, 48, and 72 hours postdose. Multiple dose: Predose (within one hour before the 1st, 3rd, and 5th dose) and 48 hours and 72 hours after the last dose.
24-hour urine calcium (efficacy)
24-hour urine calcium (24hUCa)
Time frame: Single dose: Predose (within 3 days before dosing), and 24, 48, and 72 hours postdose. Multiple dose: Predose (before each dose) and 24, 48, and 72 hours after the last dose.
Fractional Excretion of calcium (efficacy)
Fractional Excretion of calcium (FECa)
Time frame: Single dose: Predose (within one hour before dosing) and 12, 24, 36, 48, and 72 hours postdose. Multiple dose: Predose (before each dose) and 24, 48, and 72 hours after the last dose.
Procollagen type 1 N-terminal propeptide (Exploratory endpoint)
Serum Procollagen type 1 N-terminal propeptide (P1NP)
Time frame: Multiple dose: Predose (within one hour before each dose) and 24, 48, and 72 hours after the last dose.
Beta-isomerized C-terminal telopeptide of type 1 collagen (Exploratory endpoint)
Serum Beta-isomerized C-terminal telopeptide of type 1 collagen (β-CTX)
Time frame: Multiple dose: Predose (within one hour before each dose); and 24, 48, and 72 hours after the last dose.
Plan to share: No — The investigators do not plan to share Individual Participant Data (IPD) due to confidentiality agreements and participant privacy commitments.
Started Apr 2026 (actual). Primary completion is estimated for Apr 2030, 48 months after the start.
How these figures are worked out, and which studies are left out of them.
Enrollment temporarily suspended in accordance with a newly implemented regulation, State Council Decree No. 818, on clinical research and clinical translation of new biomedical technologies; pending review and approval.
Enrollment temporarily suspended in accordance with a newly implemented regulation, State Council Decree No. 818, on clinical research and clinical translation of new biomedical technologies; pending review and approval.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital →