SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects
Status unconfirmed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
This is a Phase 1/2a randomized, double-blind, two-part, dose-ascending, multicenter study of AR-501 (gallium citrate) solution, administered via inhalation, in healthy adult and P. aeruginosa infected cystic fibrosis (CF) subjects. Phase 1 of the study in HV subjects will consist of a single-ascending-dose (SAD) cohort, followed by the HV multiple-ascending-dose (MAD) cohort. Phase 2a of the study in CF subjects will consist of a MAD study design. The study will evaluate the safety and pharmacokinetic (PK) profile of single and repeat administrations of inhaled AR-501 solution in healthy adults, and the safety, PK and efficacy of repeat administrations of inhaled AR-501 solution in P. aeruginosa infected CF subjects.
Key facts
- Study ID
- NCT03669614
- Run by
- Aridis Pharmaceuticals, Inc.
- People needed
- 102
- Starts
- 2018-12-07
- Expected to finish
- 2023-07-01
- Last updated by the study team
- 2023-03-09
Who can join
Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.
Where it is running
- Research Site — Spokane, Washington, United States (enrolling)
- Research Site — Long Beach, California, United States (enrolling)
- Research Site — Denver, Colorado, United States (enrolling)
- Research Site — Gainesville, Florida, United States (enrolling)
- Research Site — Hollywood, Florida, United States (enrolling)
- Research Site — Miami, Florida, United States (enrolling)
- Research Site — Orlando, Florida, United States (enrolling)
- Research Site — Tampa, Florida, United States (enrolling)
- Research Site — Chicago, Illinois, United States (enrolling)
- Research Site — Iowa City, Iowa, United States (enrolling)
- Research Site — Tucson, Arizona, United States (enrolling)
- Research Site — Louisville, Kentucky, United States (enrolling)
- Research Site — Portland, Maine, United States (enrolling)
- Research Site — Baltimore, Maryland, United States (enrolling)
- Research Site — Detroit, Michigan, United States (enrolling)
- Research Site — Omaha, Nebraska, United States (enrolling)
- Research Site — New York, New York, United States (enrolling)
- Research Site — Cleveland, Ohio, United States (enrolling)
- Research Site — Columbus, Ohio, United States (enrolling)
- Research Site — Oklahoma City, Oklahoma, United States (enrolling)
- Research Site — Philadelphia, Pennsylvania, United States (enrolling)
- Research Site — Tyler, Texas, United States (enrolling)
- Research Site — Salt Lake City, Utah, United States (enrolling)
- Research Site — Seattle, Washington, United States (enrolling)
- Research Site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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