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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 is a Phase 1 study that has completed, run by Arcturus Therapeutics. The registered enrollment target is 16 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04442347
The ClinicalTrials.gov registry entry for NCT04442347 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arcturus Therapeutics, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04442347 reports 0 study locations.
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.
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