In Vivo Assessment of Silver Biomaterial Nano-Toxicity
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | December 2010 |
End Date: | July 2011 |
Nanotechnology is the controlled generation and manipulation of matter in dimensions less
than 100 nm. Silver has been used for its bactericidal properties. The investigators propose
to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in
human volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of
this solution.
than 100 nm. Silver has been used for its bactericidal properties. The investigators propose
to study the American Biotech Laboratory 32 ppm silver solution over a 14-day period in
human volunteers to determine the toxicity and to quantify cytochrome P450 enzyme effects of
this solution.
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.
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