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Other Closed to Enrollment
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.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
The participant must be about to receive IV tobramycin (or within 48 hours of starting it) for the treatment of an acute pulmonary exacerbation.
Study Design
-
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
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Sound Pharma -
Study Drugs:
Study Sites
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Closed to Enrollment
California
University of California San Diego, La Jolla, CA 92093
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Closed to Enrollment
District of Columbia
Children's National Medical Center, Washington, DC 20010
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Closed to Enrollment
Florida
University of Miami, Miami, FL 33136
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Closed to Enrollment
Idaho
Saint Luke's Cystic Fibrosis Center of Idaho, Boise, ID 83702
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Closed to Enrollment
Indiana
Indiana University Medical Center, Indianapolis, IN 46202
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Closed to Enrollment
Kansas
University of Kansas Medical Center, Kansas City, KS 66160
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Closed to Enrollment
Maryland
Johns Hopkins University, Baltimore, MD 21205
-
Closed to Enrollment
Missouri
Washington University School of Medicine, St. Louis, MO 63110
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Closed to Enrollment
New York
Long Island Jewish Medical Center, New Hyde Park, NY 11042
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Closed to Enrollment
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
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Closed to Enrollment
South Carolina
Medical University of South Carolina, Charleston, SC 29425
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Closed to Enrollment
Texas
University of Texas Southwestern, Dallas, TX 75390
Eligibility
See other primary eligibility criteria for more information.
-
Age:
18 Years and Older -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
40% or greater
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
The participant must be about to receive IV tobramycin (or within 48 hours of starting it) for the treatment of an acute pulmonary exacerbation.
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