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NCT04238793 · ClinicalTrials.gov registry record · Phase 1

Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy

A Phase 1 study, sponsored by Kolon Life Science.

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT04238793: Completed Phase 1 study, sponsored by Kolon Life Science.

NCT04238793 is a Phase 1 study that has completed, run by Kolon Life Science. 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

NCT04238793, a Phase 1 study, has completed, sponsored by Kolon Life Science.

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031

Primary Outcome

Frequency and nature of AEs, laboratory test results, vital sign measurements, physical and complete neurological examinations, and 12-lead electrocardiograms (ECGs)

Interventions

  • OTHER Placebo
  • DRUG KLS-2031

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2020-04-16
Est. Completion 2023-10-18
Phase Phase 1
Kolon Life Science

2 total trials

What the finished NCT04238793 record still lists

NCT04238793 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.

NCT04238793 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04238793 about?

NCT04238793 is a clinical study titled "Single Ascending Doses Study of KLS-2031 in Subjects With Neuropathic Pain From Lumbosacral Radiculopathy". Escalating single-dose design study to determine the safety, tolerability, and analgesic activity of KLS-2031

What is the current status of trial NCT04238793?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-04-16. Estimated completion is 2023-10-18.

What interventions are being tested in trial NCT04238793?

The interventions under investigation include: Placebo (OTHER), KLS-2031 (DRUG).

Who is sponsoring clinical trial NCT04238793?

This trial is sponsored by Kolon Life Science, which has 2 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04238793'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 NCT04238793, the US trial registry maintained by the National Library of Medicine. NCT04238793 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.