Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01445561 · ClinicalTrials.gov registry record · Phase 1
Ultra Low Dose Interleukin-2 in Healthy Volunteers
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT01445561 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 22 participants.
The verdict
NCT01445561, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Background: \- Interleukin-2 is a drug that can help stimulate the body s response to inflammation. High dose interleukin-2 has been used to treat different types of cancer and immune system disorders. However, it can cause frequent and often serious side effects at the doses currently used for treatment. Very low dose interleukin-2 (700 folds less than regular dose) was previously tested in cancer patients and stem cell transplant recipients. The study observed important immune changes and minimal side effects in those patients. Researchers want to test the healthy immune system's responses to very low doses of interleukin-2 to better understand how the drug works. Objectives: \- To study the effects of very low doses of interleukin-2 on healthy volunteers. Eligibility: \- Healthy volunteers at least 18 years of age. Design: * Participants will be screened with a medical history and physical exam. They will also have blood and urine samples. * Participants will receive one of two possible very low doses of interleukin-2 every day for 5 days. * Blood samples will be taken twice before the first dose, 1 day after the first dose, and before the next three doses. Followup blood samples will be taken on Days 7, 14, and 28 after the first dose.
Interventions
- DRUG Interleukin-2 (100,00 IU/m(2) SQ)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2011-09-28 |
| Est. Completion | 2013-07-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445561
The ClinicalTrials.gov registry entry for NCT01445561 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Interleukin-2 (100,00 IU/m(2) SQ) is the first listed.
NCT01445561 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01445561 about?
NCT01445561 is a clinical study titled "Ultra Low Dose Interleukin-2 in Healthy Volunteers". Background: \- Interleukin-2 is a drug that can help stimulate the body s response to inflammation. High dose interleukin-2 has been used to treat different types of cancer and immune system disorders. However, it can cause frequent and often serious side effects at the doses currently used for tre...
What is the current status of trial NCT01445561?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2011-09-28. Estimated completion is 2013-07-15.
What interventions are being tested in trial NCT01445561?
The interventions under investigation include: Interleukin-2 (100,00 IU/m(2) SQ) (DRUG).
Who is sponsoring clinical trial NCT01445561?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.