NCT01243320

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Dec 2010

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

August 25, 2015

Completed
Last Updated

August 25, 2015

Status Verified

July 1, 2015

Enrollment Period

7 months

First QC Date

November 16, 2010

Results QC Date

June 4, 2015

Last Update Submit

July 28, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (33)

  • Change in Sodium Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Potassium Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Chloride Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Carbon Dioxide Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Urea Nitrogen Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In CreatinineBlood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Glucose Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Alkaline Phosphatase Blood Level

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Aspartate Aminotransferase Blood Level

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Alanine Aminotransferase Blood Level

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Total Protein Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Total Bilirubin Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Albumin Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Calcium Blood Level

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In White Blood Count Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Red Blood Count Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Hemoglobin Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Hematocrit Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Mean Corpuscular Volume Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 days

  • Change In Mean Corpuscular Hemoglobin Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Mean Corpuscular Hemoglobin Concentration Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 days

  • Change In Platelet Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Granulocytes Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Lymphocytes Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change In Monocytes Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Basophils Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Eosinophil Blood Levels

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Sputum Reactive Oxygen Species Change

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change to Interleukin-8 Receptor

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change to Interleukin-1 Alpha Receptor

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change to Interleukin-1 Beta Receptor

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Monocyte Chemotactic Protein 1

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

  • Change in Quinone Oxidoreductase 1 Gene

    All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.

    14 Days

Secondary Outcomes (3)

  • Change Systolic Blood Pressure

    14 Days

  • Mean Change in Diastolic Blood Pressure

    14 Days

  • Mean Change in Heart Rate

    14 Days

Study Arms (2)

10ppm Oral Silver

EXPERIMENTAL

Oral Dose of 10ppm

Drug: 10ppm Oral Silver Particle

32ppm Oral Silver

EXPERIMENTAL

Oral Dose of 32ppm

Drug: 32ppm Oral Silver Particle

Interventions

10ppm Oral Silver ParticleDRUG

Silver nanoparticles at 10ppm

10ppm Oral Silver
32ppm Oral Silver ParticleDRUG

Silver nanoparticles at 32ppm

32ppm Oral Silver

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Hospital and Clinics

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • Munger MA, Radwanski P, Hadlock GC, Stoddard G, Shaaban A, Falconer J, Grainger DW, Deering-Rice CE. In vivo human time-exposure study of orally dosed commercial silver nanoparticles. Nanomedicine. 2014 Jan;10(1):1-9. doi: 10.1016/j.nano.2013.06.010. Epub 2013 Jun 28.

    PMID: 23811290DERIVED

Results Point of Contact

Title
Mark A. Munger, Pharm.D.
Organization
University of Utah
mmunger@hsc.utah.edu
8015816165

Study Officials

  • Mark A Munger, Pharm.D>

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 16, 2010

First Posted

November 18, 2010

Study Start

December 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

August 25, 2015

Results First Posted

August 25, 2015

Record last verified: 2015-07

Locations

US(1)