In Vivo Assessment of Silver Biomaterial Nano-Toxicity - Full Text View

Sponsor:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT01243320

Purpose

Hypothesis: Various time-length exposures of the American Biotech Laboratory 10 ppm silver solution will not evidence in clinically significant toxicity in healthy human volunteers.

Aim 1: Quantify Comprehensive Metabolic Panel, Urinalysis, and CBC with Platelet Count Changes from exposure to 10 ppm Silver Solution.

Routine standardized blood and urine analyses will be collected at baseline and compared to end of each time-length exposure.

Aim 2: Quantify Silver in Whole Blood and Urine by Measurement of Silver Metallic Ions (Ag0).

The daily amount of Ag0 ingested will be calculated (Intake) and compared to the collection of Ag0 serum and urine concentrations from baseline to the start of next dosing interval (Output) on the final day of each time-length exposure.

Aim 3: Quantify granulocyte and agranulocyte counts, measuring presence of reactive oxygen species (ROS), and determining presence of pro-inflammatory genetic markers from induced sputum.

Induced sputum will be collected and analyzed for white blood cell counts presence of reactive oxygen species after the last dose on the final day of time-length exposure.

Aim 4: Qualify Silver Nanoparticle Retention in Human Organ Systems On the last day of each phase of the study, all eligible subjects without will undergo a cardiac and abdominal MRI to identify retention Ag0 nanoparticles.

Condition	Intervention	Phase
Healthy Volunteers	Drug: ASAP Solution 10 ppm Drug: ASAP Solution 10 ppm Diluent	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator)
Official Title:	In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy Urine and Urination

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Quantify Comprehensive Metabolic Panel, Urinalysis, and CBC with Platelet Count Changes from exposure to 10 ppm Silver Solution. [ Time Frame: 3, 7, 14 days ] [ Designated as safety issue: Yes ]
Routine standardized blood and urine analyses will be collected at baseline and compared to end of each time-length exposure.

Secondary Outcome Measures:

Quantify Silver in Whole Blood and Urine by Measurement of Silver Metallic Ions (Ag0). [ Time Frame: 3, 7, 14 days ] [ Designated as safety issue: Yes ]
The daily amount of Ag0 ingested will be calculated (Intake) and compared to the collection of Ag0 serum and urine concentrations from baseline to the start of next dosing interval (Output) on the final day of each time-length exposure.
Quantify granulocyte and agranulocyte counts, measuring presence of reactive oxygen species (ROS), and determining presence of pro-inflammatory genetic markers from induced sputum. [ Time Frame: 3, 7, 14 days ] [ Designated as safety issue: Yes ]
Induced sputum will be collected and analyzed for white blood cell counts presence of reactive oxygen species after the last dose on the final day of time-length exposure.
Qualify Silver Nanoparticle Retention in Human Organ Systems [ Time Frame: 3, 7, 14 days ] [ Designated as safety issue: Yes ]
On the last day of each phase of the study, all eligible subjects without will undergo a cardiac and abdominal MRI to identify retention Ag0 nanoparticles.

Estimated Enrollment:	36
Study Start Date:	December 2010
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: ASAP Solution 10 ppm, Silver Biotics 10ppm Silver Nanoparticles 10 ppm Chemistry, Urinalysis, Hematology, and Whole Silver Concentration. Lung tissue via sputum analysis. Cardiac and Abdominal MRI.	Drug: ASAP Solution 10 ppm Silver nanoparticles at 10ppm Other Name: Silver Biotics 10 ppm
Placebo Comparator: Silver Biotics 10 ppm Diluent Silver Nanoparticles 10 ppm Diluent Chemistry, Urinalysis, Hematology, and Whole Silver Concentration. Lung tissue via sputum analysis. Cardiac and Abdominal MRI.	Drug: ASAP Solution 10 ppm Diluent Diluent without active ingredient

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects must be > 18-80 years old will be included.

Exclusion Criteria:

Females of child-bearing potential, defined as women physically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means will be excluded unless they are using 2 barrier birth control methods (i.e., diaphragm, condom, intrauterine device, sponge or spermicide) or hormonal contraceptive method.
Any female subject who is nursing will be excluded. Subject with has a history of heavy metal allergy (including silver) or a history of asthma or COPD or renal impairment defined by a creatinine clearance below 30 ml/min.
Subjects with symptoms of an active upper respiratory infection at time of consent will also be excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243320

Locations

United States, Utah
University of Utah Hospital and Clinics
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Mark A Munger, Pharm.D>

University of Utah

More Information

No publications provided

Responsible Party:	Mark A. Munger, Pharm.D., University of Utah
ClinicalTrials.gov Identifier:	NCT01243320 History of Changes
Other Study ID Numbers:	40281
Study First Received:	November 16, 2010
Last Updated:	July 27, 2011
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on February 21, 2012