In Vivo Assessment of Silver Biomaterial Nano-Toxicity

• 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.

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.

• Drug: ASAP Solution 10 ppm
  Silver nanoparticles at 10ppm
  Other Name: Silver Biotics 10 ppm
• Drug: ASAP Solution 10 ppm Diluent
  Diluent without active ingredient

• 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.
  Intervention: Drug: ASAP Solution 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.
  Intervention: Drug: ASAP Solution 10 ppm Diluent

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.