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Ultra Low Dose Interleukin-2 in Healthy Volunteers

NCT01445561 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-03-16

No results posted yet for this 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.

Conditions

Interventions

DRUG

Interleukin-2 (100,00 IU/m(2) SQ)

100,000 International Units/m2 SQ daily for 5 days

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Chen Zhao, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-28
Primary Completion
2013-07-15
Completion
2013-07-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01445561 on ClinicalTrials.gov