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Study of SPI-1005 in people with CF ages 18 and older (Sound Pharma SPI-3005-501.2)
This study will test the safety and tolerability of SPI-1005, a drug intended to prevent and treat hearing loss caused by aminoglycosides.
This study will be randomized and placebo-controlled. This means that some participants will receive SPI-1005 and some will receive a placebo. Participants who receive SPI-1005 will receive one of three dose levels. Researchers will measure safety and tolerability by monitoring for adverse events. They will also track how the body processes SPI-1005 by measuring symptoms of hearing loss and how much of the drug is in the blood.
This study may require hearing tests, lung function tests, blood draws, and/or other measurements.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
49 days -
Number of Study Visits:
6
Additional Information
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Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Sound Pharma -
Study Drugs:
Study Sites
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Enrolling
California
University of California San Diego, La Jolla, CA 92093
Contact
Jenna Mielke
Phone: +1 (619) 471-0822
Email: jmielke@ucsd.edu
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Enrolling Soon
District of Columbia
Children's National Medical Center, Washington, DC 20010
Contact
Beth Harkness
Phone: +1 (202) 476-2215
Email: bharknes@childrensnational.org
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Enrolling
Florida
University of Miami, Miami, FL 33136
Contact
Patricia Graham
Phone: +1 (305) 243-5545
Email: pgraham1@med.miami.edu
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Enrolling
Idaho
Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702
Contact
Lejla Godusevic
Phone: +1 (208) 381-4717
Email: godusevl@slhs.org
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Enrolling Soon
Indiana
Indiana University Medical Center, Indianapolis, IN 46202
Contact
Lisa Bendy
Phone: +1 (317) 278-7152
Email: lbendy@iu.edu
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Enrolling
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
Contact
Lawrence Scott
Phone: +1 (913) 588-4020
Email: lscott2@kumc.edu
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Enrolling Soon
Maryland
Johns Hopkins University, Baltimore, MD 21205
Contact
Britany Zeglin
Phone: +1 (443) 287-8983
Email: bzeglin1@jhmi.edu
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Enrolling
Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Tina Hicks
Phone: +1 (314) 747-2707
Email: hickst@wustl.edu
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Enrolling
New York
Long Island Jewish Medical Center, New Hyde Park, NY 11042
Contact
Aileen Espinal
Phone: +1 (516) 465-5400
Email: aespinal2@northwell.edu
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Enrolling
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
Contact
Melissa Molter
Phone: +1 (215) 662-3116
Email: melissa.molter@pennmedicine.upenn.edu
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Enrolling
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
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Enrolling
Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-2817
Email: Ashley.Keller@UTSouthwestern.edu
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