Ultra Low Dose Interleukin-2 in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 19 November 2012
• Main ID: NCT01445561
• Date of registration: 30/09/2011
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Ultra Low Dose Interleukin-2 in Healthy Volunteers
• Scientific title: The Safety and the Tolerability of Ultra Low Dose Interleukin-2 in Healthy Volunteers
• Date of first enrolment: September 2011
• Target sample size: 27
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01445561
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)

• Name: Sawa Ito, M.D.

• Name: Sawa Ito, M.D.
• Affiliation: National Heart, Lung, and Blood Institute (NHLBI)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

- Healthy volunteers confirmed by brief history and physical examination and blood work
through the CHI screening protocol

- Males or females ages 18 years or older

EXCLUSION CRITERIA:

- History of inflammatory or autoimmune disease

- History of inflammatory or autoimmune disease in first degree relatives

- History of malignancies

- Recipients of hematopoietic stem cell transplant or solid organ transplant

- History of seizures

- Positive HIV, hepatitis B surface antigen or hepatitis C antibody

- History or clinical signs of cardiac disease including coronary artery disease,
cardiac arrhythmia, congestive heart failure

- History or clinical signs of of pulmonary disease including obstructive lung disease
and asthma

- Active infections requiring systemic antibiotic therapy or anti-viral therapy

- History of systemic fungal or mycobacterial infections

- Use of immune modifying medications, i.e.- non steroidal anti-inflammatory drugs
(aspirin, ibuprofen, naproxen, celecoxib, ketrolac), steroid (prednisone,
dexamethasone, hydrocortisone), chemotherapy (cisplatin, dacarbazine, interferon
alpha, tamoxifen)

- Persons who are alcoholic or abusers of illicit drugs

- Female subjects who are or may be pregnant or lactating

- Psychiatric diagnoses or symptoms, to include hypomania, bipolar disorder, major
depression, or dysthymia

- Abnormal or marginal peripheral blood count that in the opinion of the PI will cause
Hemoglobin and Hematocrit levels to drop as a result of participation in this study

- Liver function tests above the normal laboratory reference range

- Renal function test above the normal laboratory reference range

- Contraindication to interleukin-2 (i.e. hypersensitivity to IL- 2 products, active
coronary artery disease, patients with organ allograft)

- Recent recipient of any type of vaccination (i.e. rotavirus vaccine, BCG, influenza
virus vaccine, rubella virus vaccine, mumps virus vaccine, measles vaccine,
poliovirus vaccine, smallpox vaccine, typhoid vaccine, varicella virus vaccine,
yellow fever vaccine) in the 4 weeks preceding and during active study participation

- Body mass index greater than 35

- Inability to comprehend the investigational nature of the study or provide informed
consent

- Diabetes mellitus or fasting blood glucose of > 100 mg/dL.

- Any drugs or supplements that interfere with blood clotting such as Vit.E, NSAIDS,
Warfarin (Coumadin), ticlopidine (Ticlid), clopidogrel (Plavix)

- Use of iodinated contrast media in the 4 weeks preceding and during active study
participation.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hematologic Diseases

Intervention(s)

Drug: Interleukin-2 (100,000 international units)

Drug: Interleukin-2 (200,000 international units)

Primary Outcome(s)

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]

Secondary Outcome(s)

Human immune response (immunome) to ultra low dose IL-2 based on research lab assessments [Time Frame: 4 weeks]

Secondary ID(s)

11-H-0268

110268

Source(s) of Monetary Support

Please refer to primary and secondary sponsors