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NCT01339897 · ClinicalTrials.gov registry record · Phase 1

A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects

A Phase 1 study, sponsored by Nivalis Therapeutics.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT01339897 is a Phase 1 study that has completed, run by Nivalis Therapeutics. The registered enrollment target is 25 participants.

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The verdict

NCT01339897, a Phase 1 study, has completed, sponsored by Nivalis Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

This Phase 1 study will evaluate multiple doses across a range that has been found to be effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to provide evidence of the tolerability of multiple doses as well as provide information on the Pharmacokinetic (PK) and metabolism of N6022 in humans.

Interventions

  • DRUG Placebo
  • DRUG 5 mg/N6022
  • DRUG 10mg/N6022
  • DRUG 20mg/N6022

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2011-04
Est. Completion 2011-08
Phase Phase 1

Sponsor

Nivalis Therapeutics

10 total trials

What the Registry Record Tells You About NCT01339897

The ClinicalTrials.gov registry entry for NCT01339897 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nivalis Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT01339897 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01339897 about?

NCT01339897 is a clinical study titled "A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects". This Phase 1 study will evaluate multiple doses across a range that has been found to be effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to provide evidence of the tolerability of multiple doses as well as provide information on the Pharmacokinetic (PK) and...

What is the current status of trial NCT01339897?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2011-04. Estimated completion is 2011-08.

What interventions are being tested in trial NCT01339897?

The interventions under investigation include: Placebo (DRUG), 5 mg/N6022 (DRUG), 10mg/N6022 (DRUG), 20mg/N6022 (DRUG).

Who is sponsoring clinical trial NCT01339897?

This trial is sponsored by Nivalis Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.