A Phase 1/2 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 65 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Peking Union Medical College Hospital · Phase 1/2, Interventional, and Treatment
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.
128 studies on the registry are indexed under Hypoparathyroidism; 30 are open to participants now.
This study's planned enrollment of 15 is below 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.
The criteria were revised on the registry on Sep 25, 2026. See what changed
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.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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 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 daily subcutaneous injection of 20 µg of XH-02 for 5 consecutive days
Drug: Multiple subcutaneous injection
Participants will receive a daily subcutaneous injection of 40 µg of XH-02 for 5 consecutive days
Drug: Multiple subcutaneous injection
Participants will receive a daily subcutaneous injection of 60 µg of XH-02 for 5 consecutive days
Drug: Multiple subcutaneous injection
Participants will receive a daily subcutaneous injection of 80 µg of XH-02 for 5 consecutive days
Drug: Multiple subcutaneous injection
Participants will receive a single dose of XH-02 through subcutaneous injection.
Participants will receive once daily subcutaneous injection of XH-02 for 5 consecutive days.
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 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)
serum PTH
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 calcium (efficacy)
Serum calcium
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 (efficacy)
Serum phosphorus
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 (efficacy)
Serum magnesium
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
1, 25-Dihydroxyvitamin D3 (efficacy)
Serum 1, 25-Dihydroxyvitamin D3
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.
24-hour urine calcium (efficacy)
24-hour urine calcium (24hUCa)
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
Fractional Excretion of calcium (efficacy)
Fractional Excretion of calcium (FECa)
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
Procollagen type 1 N-terminal propeptide (Exploratory endpoint)
Serum Procollagen type 1 N-terminal propeptide (P1NP)
Time frame: 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)
Serum Beta-isomerized C-terminal telopeptide of type 1 collagen (β-CTX)
Time frame: Multiple dose: Predose on Day 1 to 5 (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.
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 Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking Union Medical College Hospital →