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NCT04117711 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia
A Phase 1 study, sponsored by Applied Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 114
- Enrollment target
NCT04117711 is a Phase 1 study that has completed, run by Applied Therapeutics. The registered enrollment target is 114 participants.
The verdict
NCT04117711, a Phase 1 study, has completed, sponsored by Applied Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 114 participants
- Enrollment target
Study Summary
This study is a first-in-human, randomized, placebo-controlled, 4-Part, single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy adult subjects and adult subjects with Classic Galactosemia.
Interventions
- DRUG Placebo
- DRUG AT-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2019-06-21 |
| Est. Completion | 2021-12-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04117711
The ClinicalTrials.gov registry entry for NCT04117711 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 114 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Applied Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04117711 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04117711 about?
NCT04117711 is a clinical study titled "Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia". This study is a first-in-human, randomized, placebo-controlled, 4-Part, single ascending dose (SAD) and multiple ascending dose (MAD) study in healthy adult subjects and adult subjects with Classic Galactosemia.
What is the current status of trial NCT04117711?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 114 participants. The study started on 2019-06-21. Estimated completion is 2021-12-14.
What interventions are being tested in trial NCT04117711?
The interventions under investigation include: Placebo (DRUG), AT-007 (DRUG).
Who is sponsoring clinical trial NCT04117711?
This trial is sponsored by Applied Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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