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NCT04829435 · ClinicalTrials.gov registry record · Phase 1

Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)

A Phase 1 study, sponsored by Allena Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT04829435: Completed Phase 1 study, sponsored by Allena Pharmaceuticals.

NCT04829435 is a Phase 1 study that has completed, run by Allena Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04829435, a Phase 1 study, has completed, sponsored by Allena Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design. ALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.

Primary Outcome

Number of of participants with treatment emergent adverse events

Interventions

  • DRUG Placebo
  • DRUG ALLN-346

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2021-04-21
Est. Completion 2021-06-01
Phase Phase 1
Allena Pharmaceuticals

11 total trials

What the finished NCT04829435 record still lists

NCT04829435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04829435 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04829435 about?

NCT04829435 is a clinical study titled "Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)". The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design. ALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.

What is the current status of trial NCT04829435?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-04-21. Estimated completion is 2021-06-01.

What interventions are being tested in trial NCT04829435?

The interventions under investigation include: Placebo (DRUG), ALLN-346 (DRUG).

Who is sponsoring clinical trial NCT04829435?

This trial is sponsored by Allena Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04829435's enrollment target sits among peer trials

18 1720th of 2000 higher than 216 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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Source: ClinicalTrials.gov NCT04829435, the US trial registry maintained by the National Library of Medicine. NCT04829435 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.