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NCT01452607 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Safety and Pharmacokinetics of SPI-1005

A Phase 1 study, sponsored by Sound Pharmaceuticals, Incorporated.

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT01452607: Completed Phase 1 study, sponsored by Sound Pharmaceuticals, Incorporated.

NCT01452607 is a Phase 1 study that has completed, run by Sound Pharmaceuticals, Incorporated. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01452607, a Phase 1 study, has completed, sponsored by Sound Pharmaceuticals, Incorporated.

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.

Primary Outcome

The primary objective of this study was to evaluate the safety and tolerability of SPI-1005 (ebselen) in healthy subjects. Incidence and severity of Adverse Events were determined in all treatment and placebo groups.

Interventions

  • DRUG Placebo
  • DRUG SPI-1005

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2006-05
Est. Completion 2006-08
Phase Phase 1

What the finished NCT01452607 record still lists

NCT01452607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

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

NCT01452607 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01452607 about?

NCT01452607 is a clinical study titled "Study to Evaluate the Safety and Pharmacokinetics of SPI-1005". A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.

What is the current status of trial NCT01452607?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2006-05. Estimated completion is 2006-08.

What interventions are being tested in trial NCT01452607?

The interventions under investigation include: Placebo (DRUG), SPI-1005 (DRUG).

Who is sponsoring clinical trial NCT01452607?

This trial is sponsored by Sound Pharmaceuticals, Incorporated, which has 9 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01452607's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 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 NCT01452607, the US trial registry maintained by the National Library of Medicine. NCT01452607 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.