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NCT05315479 · ClinicalTrials.gov registry record · Phase 4

Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery

A Phase 4 study, sponsored by Baudax Bio.

Terminated
Registry status
Phase 4
Development phase
19
Enrollment target

NCT05315479: Clinical Trial Phase 4 study, sponsored by Baudax Bio.

NCT05315479 is a Phase 4 study that was terminated before completion, run by Baudax Bio. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05315479, a Phase 4 study, was terminated before completion, sponsored by Baudax Bio.

TERMINATED
Registry status
Phase 4
Development phase
19 participants
Enrollment target

Study Summary

This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to \<17 years.

Primary Outcome

Number of study subjects who experienced an AE

Interventions

  • DRUG N1539

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2022-02-24
Est. Completion 2022-07-07
Phase Phase 4
Baudax Bio

11 total trials

Why NCT05315479 stopped before completion

NCT05315479 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which N1539 is the first listed.

NCT05315479 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05315479 about?

NCT05315479 is a clinical study titled "Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery". This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to \<17 years.

What is the current status of trial NCT05315479?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2022-02-24. Estimated completion is 2022-07-07.

What interventions are being tested in trial NCT05315479?

The interventions under investigation include: N1539 (DRUG).

Who is sponsoring clinical trial NCT05315479?

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

How this trial's enrollment target compares

Where NCT05315479's enrollment target sits among peer trials

19 1834th of 2000 higher than 159 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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 NCT05315479, the US trial registry maintained by the National Library of Medicine. NCT05315479 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.