CTMX101-P1-CT002
A Phase 1b/2a Study To Evaluate The Safety Of CMTX-101 In Combination With Inhaled Tobramycin In People With Cystic Fibrosis Chronically Infected With Pseudomonas aeruginosa
- Sex: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase I/II
- Conditions Being Studied: Cystic Fibrosis (CF)
Study Purpose
Cystic Fibrosis causes the mucus in the lungs to become thick and sticky, which makes lung infection more likely. Infection with the bacterium P. aeruginosa is a leading cause of respiratory failure and death in adults with CF. The purpose of this research study is to: 1. Test the safety and tolerability of the study drug, CMTX-101 in adults with CF. 2. Measure the concentration of CMTX-101 in the blood at different timepoints following different doses of study drug. 3. Check the immune response following a single dose of CMTX-101. 4. Measure the change in the amount of P. aeruginosa bacteria in the lungs
Who Can Participate
Age: 18 years and older Received at least one 28-day cycle of inhaled tobramycin alone or CAT therapy within the last 8 weeks
Locations
UH Cleveland Medical Center
11100 Euclid Avenue
Cleveland OH, 44106
- UH IRB: SITE00002125
- StudyID: 2023-01334
- ClinicalTrials.gov: N/A
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