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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: Completed Phase 1 study, sponsored by Applied Therapeutics.
NCT04117711 is a Phase 1 study that has completed, run by Applied Therapeutics. The registered enrollment target is 114 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the safety and tolerability of AT-007 after administration to healthy subjects, including clinically-significant changes in clinical laboratory test results, physical examination findings, vital sign evaluations, and electrocardiogram results.
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 |
What the finished NCT04117711 record still lists
NCT04117711 is an interventional study that assigns participants to a tested intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (90% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04117711 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04117711's enrollment target sits among peer trials
114 507th of 2000 higher than 1,493 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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