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Anti-Infective Closed to Enrollment

Study of CMTX-101 in adults with cystic fibrosis chronically infected with Pseudomonas aeruginosa (Clarametyx CMTX101-P1-CT002 )

This study will test the safety and tolerability of a single dose of CMTX-101 delivered through an IV infusion. CMTX-101 is a drug intended to help treat infections in the lung. 

Part 1 of this study will be open label. This means that all participants will receive the study drug. Researchers will measure safety and tolerability by monitoring adverse events, changes in vital signs, and physical exams. They will also track how the body processes CMTX-101 by measuring how much of the drug is in the blood.This study may require blood draws, physical exams, and sputum collection. 

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    50% or greater

For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.

Other Primary Eligibility Criteria

To qualify for enrollment in this study, participants must have a screening P. aeruginosa density of ≥104 colony forming units (CFU)/gram of induced sputum, have a FEV1 that is ≥50% of predicted normal value at screening, and be on tobramycin alone or continuous alternating antipseudomonal therapy (CAT) with at least one 28-day cycle completed within 8 weeks prior to screening.  

Study Design

  • Study Type: ?more info

    Interventional

  • Randomized Study: ?more info

    Yes

  • Placebo Controlled: ?more info

    Yes

  • Length of Participation:

    8 weeks

  • Number of Study Visits:

    9

Additional Information

  • Phase: ?more info

    Phase One

  • Study Sponsor: ?more info

    Clarametyx BioSciences

  • Study Drugs:

    CMTX-101

Study Sites

  • Closed to Enrollment

    Alabama

    The Children's Hospital Alabama, University of Alabama at Birmingham, Birmingham, AL 35233

  • Closed to Enrollment

    California

    Stanford University Medical Center, Palo Alto, CA 94304

  • Closed to Enrollment

    Colorado

    National Jewish Health, Denver, CO 80206

  • Closed to Enrollment

    Florida

    Central Florida Pulmonary Group, Orlando, FL 32803

  • Closed to Enrollment

    Idaho

    Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702

  • Closed to Enrollment

    Kansas

    University of Kansas Medical Center, Kansas City, KS 66160

  • Closed to Enrollment

    Maryland

    Johns Hopkins University, Baltimore, MD 21205

  • Closed to Enrollment

    Massachusetts

    Boston Children's Hospital, Boston, MA 02115

  • Closed to Enrollment

    Michigan

    University of Michigan, Michigan Medicine, Ann Arbor, MI 48109

  • Closed to Enrollment

    New York

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

  • Closed to Enrollment

    Ohio

    Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195

  • 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

    Pennsylvania

    Hershey Medical Center Pennsylvania State University, Hershey, PA 17033

  • Closed to Enrollment

    Pennsylvania

    University of Pennsylvania, Philadelphia, PA 19104

  • Closed to Enrollment

    Pennsylvania

    University of Pittsburgh Medical Center, Pittsburgh, PA 15224

  • Closed to Enrollment

    South Carolina

    Medical University of South Carolina, Charleston, SC 29425

  • Closed to Enrollment

    Utah

    Adult Cystic Fibrosis Center at the University of Utah, Salt Lake City, UT 84132

  • Closed to Enrollment

    Washington

    Seattle Children's Hospital, Seattle, WA 98105

Eligibility

See other primary eligibility criteria for more information.

  • Age:

    18 Years and Older

  • Mutation(s):

    No Mutation Requirement

  • FEV1% Predicted:

    50% 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

To qualify for enrollment in this study, participants must have a screening P. aeruginosa density of ≥104 colony forming units (CFU)/gram of induced sputum, have a FEV1 that is ≥50% of predicted normal value at screening, and be on tobramycin alone or continuous alternating antipseudomonal therapy (CAT) with at least one 28-day cycle completed within 8 weeks prior to screening.  

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