Page Title
Clinical Trial Finder
Other Enrolling
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.
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:
40% or greater
For a more comprehensive list of eligibility criteria and details on this study, 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
-
Enrolling
California
University of California San Diego, La Jolla, CA 92093
Contact
Gabriel Querido
Phone: +1
Email: glquerido@health.ucsd.edu
-
Closed to Enrollment
Florida
University of Miami, Miami, FL 33136
-
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
-
Enrolling
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 (443) 287-8983
Email: jpinto4@jh.edu
-
Enrolling
Missouri
Washington University School of Medicine, St. Louis, MO 63110
Contact
Irma Bauer
Phone: +1 (314) 747-2940
Email: irmabauer@wustl.edu
-
Closed to Enrollment
New York
Long Island Jewish Medical Center, New Hyde Park, NY 11042
-
Closed to Enrollment
Pennsylvania
University of Pennsylvania, Philadelphia, PA 19104
-
Enrolling
South Carolina
Medical University of South Carolina, Charleston, SC 29425
Contact
Ashley Warden
Phone: +1 (843) 792-4349
Email: jonesash@musc.edu
-
Enrolling
Texas
University of Texas Southwestern, Dallas, TX 75390
Contact
Ashley Keller
Phone: +1 (214) 648-6233
Email: Ashley.Keller@UTSouthwestern.edu
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:
40% or greater
For a more comprehensive list of eligibility criteria and details on this study, 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.
Related Topics
Sign up for clinical trial alerts
Get email updates about clinical trials that matter to you.
Check the Drug Development Pipeline
We’re attacking CF from every angle. Learn about the status of CF drugs in development.
Learn More