In Vivo Assessment of Silver Biomaterial Nano-Toxicity

Utah System of Higher Education (USHE)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy

Treatments

Drug: 32ppm Oral Silver Particle

Drug: 10ppm Oral Silver Particle

Study type

Interventional

Funder types

Other

Identifiers

NCT01243320

40281

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.