In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Completed · Phase 1/Phase 2

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01243320

Run by

University of Utah

People needed

36

Starts

2010-12-01

Expected to finish

2011-07-01

Last updated by the study team

2015-08-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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