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NCT07541209 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of PTH-IA
A Phase 1 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT07541209 is a Phase 1 study that is actively recruiting participants, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 12 participants.
The verdict
NCT07541209, a Phase 1 study, is actively recruiting participants, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Jansen s Metaphyseal Chondrodysplasia (JMC) is a very rare disorder with only approximately 30 people known to have the disease worldwide. It is caused by parathyroid hormone 1 receptor (PTH1R) variants leading to constitutive activation of the receptor for parathyroid hormone (PTH) and parathyroid hormone-related peptide (PTHrP). PTH1R is predominantly expressed in the kidneys and bone and growth-plate chondrocytes. Individuals with JMC develop severe growth impairment resulting in significant short stature, scoliosis, frequent fractures, bone pain, mineral-ion abnormalities (typically hypercalcemia and hypercalciuria), hypertension, and chronic kidney disease due to nephrocalcinosis and nephrolithiasis. Children often undergo multiple surgeries for skeletal fractures and deformities; mobility is commonly impaired, usually requiring assistive devices for ambulation. Other complications may include premature closure of cranial sutures and cranial nerve compressions with the potential for vision and/or hearing loss \[1-3\]. Physical function impairment and the need for complication-related operations have profound deleterious effects on quality of life in individuals with JMC. There are currently no approved therapies for JMC, and novel therapies are critically needed to prevent irreversible disease complications and improve patient quality of life. The inventors of the drug, parathyroid hormone inverse agonist (PTH-IA), have considerable expertise in both the basic and clinical aspects of PTH/PTHrP receptor molecular biology and pharmacology. They reported the first PTH1R JMC mutations (including the H223R mutation) over 20 years ago and identified certain PTH antagonist ligands that function as inverse agonists on the PTH1R JMC mutant receptors \[2, 4\]. These ligands suppress the mutant receptor s elevated basal rates of cAMP signalling, as assessed in cultured cells and animal models. In vivo studies confirm that inverse agonist ligands may be effective in treat
Interventions
- DRUG PTH-IA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-05-27 |
| Est. Completion | 2029-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07541209
The ClinicalTrials.gov registry entry for NCT07541209 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which PTH-IA is the first listed.
NCT07541209 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07541209 about?
NCT07541209 is a clinical study titled "Safety and Efficacy of PTH-IA". Jansen s Metaphyseal Chondrodysplasia (JMC) is a very rare disorder with only approximately 30 people known to have the disease worldwide. It is caused by parathyroid hormone 1 receptor (PTH1R) variants leading to constitutive activation of the receptor for parathyroid hormone (PTH) and parathyroid ...
What is the current status of trial NCT07541209?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-05-27. Estimated completion is 2029-06-01.
What interventions are being tested in trial NCT07541209?
The interventions under investigation include: PTH-IA (DRUG).
Who is sponsoring clinical trial NCT07541209?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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