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Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis

NCT04375514 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-12-17

Study results available
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Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single doses of ARO-ENaC in healthy adult volunteers; and to evaluate the safety, tolerability, PK and efficacy of multiple doses of ARO-ENaC in patients with pulmonary cystic fibrosis.

Conditions

  • Cystic Fibrosis, Pulmonary

Interventions

DRUG

ARO-ENaC

single or multiple doses of ARO-ENaC by inhalation of nebulized solution

DRUG

Placebo

calculated volume of normal saline to match active treatment by inhalation of nebulized solution

Sponsors & Collaborators

  • Arrowhead Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-30
Primary Completion
2021-05-09
Completion
2022-05-13
FDA Drug
Yes

Countries

  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04375514 on ClinicalTrials.gov