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NCT07640984 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Trial of JR-446 in Mucopolysaccharidosis Type IIIB (MPS IIIB)
A Phase 1 study, sponsored by JCR Pharmaceuticals Co..
- Not yet
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT07640984: Clinical Trial Phase 1 study, sponsored by JCR Pharmaceuticals Co..
NCT07640984 is a Phase 1 study that has not yet begun recruiting, run by JCR Pharmaceuticals Co.. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07640984, a Phase 1 study, has not yet begun recruiting, sponsored by JCR Pharmaceuticals Co..
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a global, open-label, Phase I/II, interventional trial in participants younger than 6 years of age with Mucopolysaccharidosis Type IIIB (MPS IIIB), designed to assess the safety and tolerability of JR-446, determine its pharmacodynamic effects, and explore its potential to demonstrate early clinical effects on disease-relevant outcomes.
Primary Outcome
Incidence and severity of treatment-emergent adverse events; Incidence and severity of infusion-associated reactions; Incidence of clinically significant changes/abnormalities in safety laboratory tests, vital signs, and electrocardiogram.
Interventions
- DRUG JR-446
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-06-18 |
| Est. Completion | 2028-09-30 |
| Phase | Phase 1 |
What is known before NCT07640984 opens enrollment
NCT07640984 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which JR-446 is the first listed.
NCT07640984 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07640984 about?
NCT07640984 is a clinical study titled "A Phase I/II Trial of JR-446 in Mucopolysaccharidosis Type IIIB (MPS IIIB)". This is a global, open-label, Phase I/II, interventional trial in participants younger than 6 years of age with Mucopolysaccharidosis Type IIIB (MPS IIIB), designed to assess the safety and tolerability of JR-446, determine its pharmacodynamic effects, and explore its potential to demonstrate early ...
What is the current status of trial NCT07640984?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2026-06-18. Estimated completion is 2028-09-30.
What interventions are being tested in trial NCT07640984?
The interventions under investigation include: JR-446 (DRUG).
Who is sponsoring clinical trial NCT07640984?
This trial is sponsored by JCR Pharmaceuticals Co., which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07640984's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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