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NCT04236219 · ClinicalTrials.gov registry record · Phase 1
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
A Phase 1 study, sponsored by Allena Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04236219: Completed Phase 1 study, sponsored by Allena Pharmaceuticals.
NCT04236219 is a Phase 1 study that has completed, run by Allena Pharmaceuticals. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04236219, a Phase 1 study, has completed, sponsored by Allena Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.
Primary Outcome
Number of participants with treatment emergent adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Interventions
- DRUG Placebo
- DRUG ALLN-346
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-09-02 |
| Est. Completion | 2020-11-06 |
| Phase | Phase 1 |
What the finished NCT04236219 record still lists
NCT04236219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04236219 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04236219 about?
NCT04236219 is a clinical study titled "ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers". The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.
What is the current status of trial NCT04236219?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-09-02. Estimated completion is 2020-11-06.
What interventions are being tested in trial NCT04236219?
The interventions under investigation include: Placebo (DRUG), ALLN-346 (DRUG).
Who is sponsoring clinical trial NCT04236219?
This trial is sponsored by Allena Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04236219's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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