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NCT02027155 · ClinicalTrials.gov registry record · Phase 1
Phase I Rising-dose Study to Assess Tolerability, Safety, Pharmacokinetics, Pharmacodynamics of AR09
A Phase 1 study, sponsored by Arbor Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT02027155: Clinical Trial Phase 1 study, sponsored by Arbor Pharmaceuticals.
NCT02027155 is a Phase 1 study that was terminated before completion, run by Arbor Pharmaceuticals. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02027155, a Phase 1 study, was terminated before completion, sponsored by Arbor Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.
Primary Outcome
Incidence of treatment-emergent adverse events (AE) by dose, including changes in temperature, respiratory rate, respiratory function at specified intervals post-dosing up to 24 hours. * Treatment-emergent changes in 12-lead electrocardiogram (ECG) recordings compared to pre-dose at specified intervals post-dosing and at Follow-Up including changes in heart rate and rhythm by dose at specified intervals post-dosing through 24 hours. * Treatment-emergent changes in group mean systolic and group
Interventions
- DRUG placebo
- DRUG AR09 solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2013-12 |
| Est. Completion | 2014-04 |
| Phase | Phase 1 |
Why NCT02027155 stopped before completion
NCT02027155 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02027155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02027155 about?
NCT02027155 is a clinical study titled "Phase I Rising-dose Study to Assess Tolerability, Safety, Pharmacokinetics, Pharmacodynamics of AR09". This will be a randomized, double-blind, placebo-controlled, rising-dose study of single IV doses of AR09 in healthy subjects. Each infusion will occur over 10 minutes.
What is the current status of trial NCT02027155?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2013-12. Estimated completion is 2014-04.
What interventions are being tested in trial NCT02027155?
The interventions under investigation include: placebo (DRUG), AR09 solution (DRUG).
Who is sponsoring clinical trial NCT02027155?
This trial is sponsored by Arbor Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02027155's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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