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Anti-Infective Closed to Enrollment

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.

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 more information about the results of this study and where it was conducted, 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:

    AR-501 (Panaecin™)

Study Sites

  • Closed to Enrollment

    Arizona

    Tucson Cystic Fibrosis Center, Tucson, AZ 85724

  • Closed to Enrollment

    California

    Miller Children's and Women's Hospital Long Beach, Long Beach, CA 90806

  • Closed to Enrollment

    Colorado

    National Jewish Health, Denver, CO 80206

  • Closed to Enrollment

    Florida

    Tampa General Hospital, Tampa, FL 33606

  • Closed to Enrollment

    Florida

    University of Florida, Gainesville, FL 32610

  • Closed to Enrollment

    Florida

    University of Miami, Miami, FL 33136

  • Closed to Enrollment

    Florida

    Joe DiMaggio Children's Hospital, Hollywood, FL 33021

  • Closed to Enrollment

    Iowa

    University of Iowa, Iowa City, IA 52242

  • Closed to Enrollment

    Kentucky

    University of Louisville, Louisville, KY 40202

  • Closed to Enrollment

    Maine

    Maine Medical Center, Portland, ME 04102

  • Closed to Enrollment

    Maryland

    Johns Hopkins University, Baltimore, MD 21287

  • Closed to Enrollment

    Michigan

    Wayne State University Harper University Hospital, Detroit, MI 48201

  • Closed to Enrollment

    Nebraska

    University of Nebraska Medical Center, Omaha, NE 68198

  • Closed to Enrollment

    New York

    New York Medical College at Westchester Medical Center, Valhalla, NY 10595

  • Closed to Enrollment

    Ohio

    Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center, Cleveland, OH 44106

  • Closed to Enrollment

    Ohio

    Nationwide Children's Hospital, Columbus, OH 43205

  • Closed to Enrollment

    Oklahoma

    Oklahoma Cystic Fibrosis Center, OKC, OK 73104

  • Closed to Enrollment

    Pennsylvania

    University of Pennsylvania, Philadelphia, PA 19104

  • Closed to Enrollment

    Texas

    University of Texas Health Center at Tyler, Tyler, TX 75708

  • Closed to Enrollment

    Utah

    Intermountain Cystic Fibrosis Center, University of Utah, Salt Lake City, UT 84132

  • Closed to Enrollment

    Virginia

    Inova Fairfax, Falls Church, VA 22042

  • Closed to Enrollment

    Washington

    Providence Medical Group, Cystic Fibrosis Clinic, Spokane, WA 99204

  • Closed to Enrollment

    Washington

    University of Washington Medical Center, Seattle, WA 98195

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 more information about the results of this study and where it was conducted, 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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