Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00554359 · ClinicalTrials.gov registry record · Phase 1
A Dose Escalation and Safety Study of I5NP in Patients Undergoing Major Cardiovascular Surgery
A Phase 1 study, sponsored by Quark Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT00554359: Completed Phase 1 study, sponsored by Quark Pharmaceuticals.
NCT00554359 is a Phase 1 study that has completed, run by Quark Pharmaceuticals. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00554359, a Phase 1 study, has completed, sponsored by Quark Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 8-10 centers in the United States and Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will participate. Patients will receive a single IV injection of I5NP or placebo following cardiovascular surgery. I5NP will be administered 4 hours (+/- 30 minutes) following removal of the cardiopulmonary bypass machine (CBM). The duration of the study is approximately 44 days, inclusive of a 14 day screening period. Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 and Day 7 or hospital discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls will be made at 6 and 12 months after date of surgery.
Interventions
- DRUG placebo
- DRUG I5NP (a small interfering RNA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-08 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
What the finished NCT00554359 record still lists
NCT00554359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00554359 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00554359 about?
NCT00554359 is a clinical study titled "A Dose Escalation and Safety Study of I5NP in Patients Undergoing Major Cardiovascular Surgery". This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic study. The study will be conducted in approximately 8-10 centers in the United States and Switzerland. Up to 32 patients who have undergone major cardiovascular surgery will participate. Patients will receive a ...
What is the current status of trial NCT00554359?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2007-08. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00554359?
The interventions under investigation include: placebo (DRUG), I5NP (a small interfering RNA) (DRUG).
Who is sponsoring clinical trial NCT00554359?
This trial is sponsored by Quark Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00554359's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02422641 · 16 participants · Phase 2
Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis
- NCT02851758 · 16 participants · NA
Transplantation of Autologously Derived Mitochondria Following Ischemia
- NCT03291028 · 16 participants
Analysis of Primary and Metastatic Tumors in Patients With Renal Cell Carcinoma and Urothelial Carcinoma
- NCT03425526 · 16 participants · Phase 1
Donor T Cell Therapy in Treating Immunocompromised Patients With Adenovirus-Related Disease
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia