Page Title
Clinical Trial Finder
Anti-Infective Enrolling
Study to evaluate inhaled AR-501 in healthy adults and adults with cystic fibrosis and Pseudomonas aeruginosa (Aridis AR-501-001 MAD cohorts)
This study is testing inhaled AR-501, a drug intended to treat infections in the lung. The study will measure the drug’s safety, how well it works, and how the body processes it. Multiple doses of AR-501 will be tested in both healthy adults and adults with cystic fibrosis who are infected with Pseudomonas aeruginosa to find the best dose.
This study will take place in two parts that are both randomized and placebo-controlled. This means that some participants will be randomly assigned to receive the study drug, and some participants will be randomly assigned to receive placebo.
In part 1, healthy volunteers will be given both single and multiple doses of either AR-501 or placebo. In part 2, adults with cystic fibrosis will be given one of three different dose levels of either AR-501 or placebo. Each participant will receive a total of three doses, with each dose one week apart. Researchers will measure safety by monitoring for adverse events. They will also track how the body processes AR-501 by measuring how much of the drug stays in the bloodstream over a period of time.
This study may require blood draws, lung function tests, and sputum or throat swab collection.
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
45% or greater
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Confirmation of current colonization/infection with P. aeruginosa defined as: a positive sputum or oropharyngeal swab culture at screening.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
6 weeks -
Number of Study Visits:
11
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Aridis Pharmaceuticals -
Study Drugs:
Study Sites
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Enrolling
Arizona
Tucson Cystic Fibrosis Center, Tucson, AZ 85724
Contact
Elizabeth Ryan
Phone: +1 (520) 850-8688
Email: elizabethryan@arizona.edu
-
Enrolling
California
Miller Children's and Women's Hospital Long Beach, Long Beach, CA 90806
Contact
Marylee Melendrez
Phone: +1 (562) 933-1851
Email: mmelendrez@memorialcare.org
-
Enrolling
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2517
Email: wilsona@njhealth.org
-
Enrolling
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Kathleen Summo
Phone: +1 (407) 841-1100
Email: ksummo@cfpulmonary.com
-
Enrolling
Florida
Tampa General Hospital, Tampa, FL 33606
Contact
Andrew Marino
Phone: +1 (813) 844-4907
Email: amarino@tgh.org
-
Enrolling
Florida
University of Florida, Gainesville, FL 32610
Contact
Alexa Smith
Phone: +1
Email: alexa.howell@ufl.edu
-
Closed to Enrollment
Florida
University of Miami, Miami, FL 33136
-
Enrolling
Florida
Joe DiMaggio Children's Hospital, Hollywood, FL 33021
Contact
Doris Alaby
Phone: +1 (954) 265-1863
Email: dalaby@mhs.net
-
Enrolling
Iowa
University of Iowa, Iowa City, IA 52242
Contact
Mary Teresi
Phone: +1 (319) 384-7546
Email: mary-teresi@uiowa.edu
-
Enrolling
Kentucky
University of Louisville, Louisville, KY 40202
Contact
Melissa Thomas
Phone: +1
Email: mcthom12@louisville.edu
-
Enrolling
Maine
Maine Medical Center, Portland, ME 04102
Contact
Harmony Renna
Phone: +1 (207) 662-5917
Email: Harmony.Renna@mainehealth.org
-
Enrolling
Maryland
Johns Hopkins University, Baltimore, MD 21287
Contact
Jeanne Pinto
Phone: +1 (443) 287-8983
Email: jpinto4@jh.edu
-
Enrolling
Michigan
Wayne State University Harper University Hospital, Detroit, MI 48201
Contact
Debra Driscoll
Phone: +1 (313) 745-2221
Email: ddriscol@med.wayne.edu
-
Enrolling
Nebraska
University of Nebraska Medical Center, Omaha, NE 68198
Contact
Michel Veit
Phone: +1 (402) 559-7585
Email: michel.veit@unmc.edu
-
Enrolling
New York
New York Medical College at Westchester Medical Center, Valhalla, NY 10595
Contact
Zachary Messer
Phone: +1 (914) 594-2352
Email: Zachary_Messer@nymc.edu
-
Enrolling
Ohio
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106
Contact
Primary RC & Participant Contact General Contact
Phone: +1
Email: RainbowCFResearch@UHhospitals.org
-
Enrolling
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling
Oklahoma
Oklahoma Cystic Fibrosis Center, OKC, OK 73104
Contact
Participant Contact Oklahoma Cystic Fibrosis Center
Phone: +1 (405) 271-6216
Email: cfresearchteam@ouhsc.edu
-
Enrolling
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.edu
-
Enrolling
Texas
University of Texas Health Center at Tyler, Tyler, TX 75708
Contact
Debbie Fielder
Phone: +1 (903) 877-7753
Email: debbie.fielder@uthct.edu
-
Enrolling
Utah
Intermountain Cystic Fibrosis Center, University of Utah, Salt Lake City, UT 84132
Contact
Kristyn Packer
Phone: +1 (801) 585-0401
Email: kristyn.packer@hsc.utah.edu
-
Enrolling Soon
Virginia
Inova Fairfax, Falls Church, VA 22042
Contact
Phone: +1
Email:
-
Enrolling
Washington
Providence Medical Group, Cystic Fibrosis Clinic, Spokane, WA 99204
Contact
Joan Milton
Phone: +1 (509) 474-4323
Email: joan.milton@providence.org
-
Enrolling
Washington
University of Washington Medical Center, Seattle, WA 98195
Contact
Teresa Gambol
Phone: +1 (206) 543-7382
Email: TGambol@medicine.washington.edu
Email a research coordinator to express interest in participating in this study.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
45% or greater -
Pseudomonas Status:
Positive Respiratory Cultures Required
For a more comprehensive list of eligibility criteria and details on this study, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Confirmation of current colonization/infection with P. aeruginosa defined as: a positive sputum or oropharyngeal swab culture at screening.
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