This study aims to evaluate the safety and efficacy of a novel PTH replacement therapy drug in patients with hypoparathyroidism. The drug is an mRNA drug which will be translated into PTH after intravenous administration, to achieve the therapeutic effect.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
intravenous administration of PTH1-84 mRNA
Peking Union Medical College Hospital
Beijing, China
AE and SAE
adverse event (AE) and severe adverse event (SAE) via regular vital sign checks, physical examinations, and safety laboratory tests (including complete blood count, blood biochemistry, coagulation profile, C-reactive protein, urinalysis, cardiac ultrasound, and electrocardiogram).
Time frame: the whole study period including the screening, treatment, and follow-up period. Follow-up period extends to 90 days after administration.
PTH1-84
serum PTH1-84
Time frame: Before (within 1 hour) and 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration
PTH
serum PTH
Time frame: Before (within 1 hour) and 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration
serum calcium
serum calcium
Time frame: Before (within 1 hour) and 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration
Serum magnesium
Serum magnesium
Time frame: Before (within 1 hour) and 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration
Serum phosphorus
Serum phosphorus
Time frame: Before (within 1 hour) and 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration
1,25-dihydroxyvitamin D
serum 1,25-dihydroxyvitamin D
Time frame: Before (within 1 hour) and 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fractional excretion of calcium (FECa)
FECa (%) = (Urine Calcium × Serum Creatinine) / (Serum Calcium × Urine Creatinine) × 100
Time frame: Before (within 1 hour) and 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours after administration
24-hour urinary calcium
24-hour urinary calcium
Time frame: Before (within 3 days) and 24 hours, 48 hours, 72 hours after administration
Procollagen type I N-terminal propeptide (P1NP)
serum procollagen type I N-terminal propeptide (P1NP)
Time frame: Before (within 1 hour) and 24 hours, 48 hours, 72 hours after administration
Type I collagen cross-linked C-telopeptide (β-CTX)
serum type I collagen cross-linked C-telopeptide (β-CTX)
Time frame: Before (within 1 hour) and 24 hours, 48 hours, 72 hours after administration