Clinical trialNCT03669614UnknownPhase 1/PHASE2Interventional

SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects

SponsorAridis Pharmaceuticals, Inc.Enrollment102Cystic Fibrosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Alan H Cohen, MD
Aridis Pharmaceuticals, Inc.
Study Director
clinicaltrials.gov ↗
Hasan S Jafri, MD, FAAP
Aridis Pharmaceuticals, Inc.
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

25 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Research Site
Tucson, Arizona, United States
Recruiting
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Long Beach, California, United States
Recruiting
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Denver, Colorado, United States
Recruiting
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Gainesville, Florida, United States
Recruiting
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Hollywood, Florida, United States
Recruiting
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Miami, Florida, United States
Recruiting
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Orlando, Florida, United States
Recruiting
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Tampa, Florida, United States
Recruiting
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Chicago, Illinois, United States
Recruiting
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Iowa City, Iowa, United States
Recruiting
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Overland Park, Kansas, United States
Completed
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Louisville, Kentucky, United States
Recruiting
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Portland, Maine, United States
Recruiting
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Baltimore, Maryland, United States
Recruiting
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Detroit, Michigan, United States
Recruiting
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Omaha, Nebraska, United States
Recruiting
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New York, New York, United States
Recruiting
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Cleveland, Ohio, United States
Recruiting
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Columbus, Ohio, United States
Recruiting
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Oklahoma City, Oklahoma, United States
Recruiting
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Philadelphia, Pennsylvania, United States
Recruiting
Research Site
Tyler, Texas, United States
Recruiting
Research Site
Salt Lake City, Utah, United States
Recruiting
Research Site
Seattle, Washington, United States
Recruiting
Research Site
Spokane, Washington, United States
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Inhaled AR-501Inhaled Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 7 Dec 2018
Primary completion: 31 Jul 2023
Completion: 31 Jul 2023
Last update posted: 9 Mar 2023
Registered enrollment: 102
Registry id: NCT03669614

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.