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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: Completed Phase 1 study, sponsored by Nivalis Therapeutics.
NCT01339897 is a Phase 1 study that has completed, run by Nivalis Therapeutics. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety variables (adverse events, vital signs, physical examination, telemetry, 12-lead ECG, infusion site reactions, O2 saturation, and clinical laboratory assessments)
Interventions
- DRUG Placebo
- DRUG 5 mg/N6022
- DRUG 10mg/N6022
- DRUG 20mg/N6022
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-04 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT01339897 record still lists
NCT01339897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01339897 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01339897's enrollment target sits among peer trials
25 1495th of 2000 higher than 481 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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