Study Overview
This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
Description
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.
Official Title
A Phase 1/2a Randomized, Double-Blind, Two-Part, Dose-Ascending, Multicenter Study of the Safety and PK of AR-501 (Gallium Citrate), Administered Via Inhalation, in Healthy Adult and P. Aeruginosa Infected Cystic Fibrosis Subjects
Quick Facts
Study Start:2018-12-07
Study Completion:2023-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Contacts and Locations
Study Locations (Sites)
Research Site
Tucson, Arizona, 85724
United States
Research Site
Long Beach, California, 90806
United States
Research Site
Denver, Colorado, 80206
United States
Research Site
Gainesville, Florida, 32610
United States
Research Site
Hollywood, Florida, 33021
United States
Research Site
Miami, Florida, 33136
United States
Research Site
Orlando, Florida, 32803
United States
Research Site
Tampa, Florida, 33606
United States
Research Site
Chicago, Illinois, 60093
United States
Research Site
Iowa City, Iowa, 55242
United States
Research Site
Overland Park, Kansas, 66212
United States
Research Site
Louisville, Kentucky, 40202
United States
Research Site
Portland, Maine, 04102
United States
Research Site
Baltimore, Maryland, 21204
United States
Research Site
Detroit, Michigan, 48201
United States
Research Site
Omaha, Nebraska, 68198
United States
Research Site
New York, New York, 10532
United States
Research Site
Cleveland, Ohio, 44106
United States
Research Site
Columbus, Ohio, 43205
United States
Research Site
Oklahoma City, Oklahoma, 73104
United States
Research Site
Philadelphia, Pennsylvania, 19104
United States
Research Site
Tyler, Texas, 75708
United States
Research Site
Salt Lake City, Utah, 84132
United States
Research Site
Seattle, Washington, 98195
United States
Research Site
Spokane, Washington, 99204
United States
Collaborators and Investigators
Sponsor: Aridis Pharmaceuticals, Inc.
- Hasan S Jafri, MD, FAAP, STUDY_DIRECTOR, Aridis Pharmaceuticals, Inc.
- Alan H Cohen, MD, STUDY_DIRECTOR, Aridis Pharmaceuticals, Inc.
Study Record Dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
Study Start Date2018-12-07
Study Completion Date2023-07
Study Record Updates
Study Start Date2018-12-07
Study Completion Date2023-07
Terms related to this study
Keywords Provided by Researchers
- Cystic Fibrosis
- Gallium Citrate
- Pseudomonas Aeruginosa
Additional Relevant MeSH Terms