Page Title
Clinical Trial Finder
Anti-Infective Enrolling
Study of CMTX-101 in adults with cystic fibrosis chronically infected with Pseudomonas aeruginosa (Clarametyx CMTX101-P1-CT002 SAD)
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.
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:
50% or greater
For a more comprehensive list of eligibility criteria and details on this study, 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:
Study Sites
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Enrolling
Colorado
National Jewish Health, Denver, CO 80206
Contact
Alix Wilson
Phone: +1 (303) 270-2517
Email: wilsona@njhealth.org
-
Enrolling Soon
Florida
Central Florida Pulmonary Group, Orlando, FL 32803
Contact
Desiree Serr
Phone: +1 (407) 841-1100
Email: dserr@cfpulmonary.com
-
Enrolling Soon
Idaho
Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702
Contact
Lejla Godusevic
Phone: +1 (208) 381-4717
Email: godusevl@slhs.org
-
Enrolling Soon
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
-
Enrolling Soon
Maryland
Johns Hopkins University, Baltimore, MD 21205
Contact
Jeanne Pinto
Phone: +1 (410) 955-9782
Email: jpinto4@jh.edu
-
Enrolling Soon
Massachusetts
Boston Children's Hospital, Boston, MA 02115
Contact
Robert Fowler
Phone: +1 (617) 355-1834
Email: Robert.fowler@childrens.harvard.edu
-
Enrolling Soon
Michigan
University of Michigan, Michigan Medicine, Ann Arbor, MI 48109
Contact
Dawn Kruse
Phone: +1 (734) 615-3266
Email: dmkruse@med.umich.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 Soon
Ohio
Cleveland Clinic Cystic Fibrosis Program, Cleveland, OH 44195
Contact
Dave Weaver
Phone: +1 (216) 445-6671
Email: weaverd@ccf.org
-
Enrolling Soon
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 Soon
Ohio
Nationwide Children's Hospital, Columbus, OH 43205
Contact
Diana Gilmore
Phone: +1 (614) 722-4752
Email: diana.gilmore@nationwidechildrens.org
-
Enrolling Soon
Pennsylvania
Hershey Medical Center Pennsylvania State University, Hershey, PA 17033
Contact
Diane Kitch
Phone: +1 (717) 531-5646
Email: dkitch@pennstatehealth.psu.edu
-
Enrolling Soon
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.edu
-
Enrolling Soon
Pennsylvania
University of Pittsburgh Medical Center, Pittsburgh, PA 15224
Contact
Elizabeth Hartigan
Phone: +1 (412) 692-7060
Email: elizabeth.hartigan@chp.edu
-
Enrolling Soon
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
-
Enrolling Soon
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
Washington
Seattle Children's Hospital, Seattle, WA 98105
Contact
Sharon McNamara
Phone: +1 (206) 987-3921
Email: sharon.mcnamara@seattlechildrens.org
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:
50% 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
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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