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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: Completed Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To determine the safety and the tolerability of ultra low dose (physiologic dose) interleukin-2 in healthy volunteers
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 |
What the finished NCT01445561 record still lists
NCT01445561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
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 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01445561's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 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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