Ultra Low Dose Interleukin-2 in Healthy Volunteers
- 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.
- To study the effects of very low doses of interleukin-2 on healthy volunteers.
- Healthy volunteers at least 18 years of age.
- 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.
|Hematologic Diseases||Drug: Interleukin-2 (100,000 international units) Drug: Interleukin-2 (200,000 international units)||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
|Official Title:||The Safety and the Tolerability of Ultra Low Dose Interleukin-2 in Healthy Volunteers|
- Safety and tolerability of ultra low dose IL-2 [ Time Frame: 4 weeks ]
- TRSAE rate of no more than 5 percent would allow us to proceed with future studies. [ Time Frame: 4 weeks ]
- Human immune response (immunome) to ultra low dose IL-2 based on research lab assessments [ Time Frame: 4 weeks ]
|Study Start Date:||September 26, 2011|
|Study Completion Date:||July 15, 2013|
|Primary Completion Date:||July 15, 2013 (Final data collection date for primary outcome measure)|
Experimental: Cohort 1
Interleukin-2 100,000 international units/m2 daily for 5 days
Drug: Interleukin-2 (100,000 international units)
100,000 international units/m2 daily for 5 days
Experimental: Cohort 2
Interleukin-2 200,000 international units/m2 daily for 5 days
Drug: Interleukin-2 (200,000 international units)
200,000 international units/m2 daily for 5 days
Please refer to this study by its ClinicalTrials.gov identifier: NCT01445561
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Sawa Ito, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|