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NCT04442347 · ClinicalTrials.gov registry record · Phase 1
Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency
A Phase 1 study, sponsored by Arcturus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT04442347: Completed Phase 1 study, sponsored by Arcturus Therapeutics.
NCT04442347 is a Phase 1 study that has completed, run by Arcturus Therapeutics. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04442347, a Phase 1 study, has completed, sponsored by Arcturus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in clinically stable patients (stable on standard of care treatment, e.g. diet ± ammonia scavengers) with ornithine transcarbamylase deficiency (OTCD).
Primary Outcome
Safety and tolerability of ARCT-810 assessed by determining the incidence, severity and dose-relationship of AEs by dose
Interventions
- OTHER Placebo
- BIOLOGICAL ARCT-810
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2020-11-03 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 1 |
What the finished NCT04442347 record still lists
NCT04442347 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04442347 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04442347 about?
NCT04442347 is a clinical study titled "Phase 1b Study to Assess Safety, Tolerability, and Pharmacokinetics of ARCT-810 in Stable Adult Subjects With Ornithine Transcarbamylase Deficiency". Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in clinically stable patients (stable on standard of care treatment, e.g. diet ± ammonia scavengers) with ornithine transcarbamylase deficiency (OTCD).
What is the current status of trial NCT04442347?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2020-11-03. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT04442347?
The interventions under investigation include: Placebo (OTHER), ARCT-810 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04442347?
This trial is sponsored by Arcturus Therapeutics, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04442347's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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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