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

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05604495` - Screening for Cystic Fibrosis and Cystic Fibrosis Related Disorders in Chinese Adults With Bronchiectasis
Not yet recruiting	`NCT06339450` - Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects	N/A
Active, not recruiting	`NCT06084468` - Cardiac Structure and Function in Patients With Cystic Fibrosis
Completed	`NCT03437811` - Airway Clearance System (K031876) Phase IV Device Efficacy

See also

Status

Clinical Trial

Phase

Recruiting

NCT05604495 - Screening for Cystic Fibrosis and Cystic Fibrosis Related Disorders in Chinese Adults With Bronchiectasis

Not yet recruiting

NCT06339450 - Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects

N/A

Active, not recruiting

NCT06084468 - Cardiac Structure and Function in Patients With Cystic Fibrosis

Completed

NCT03437811 - Airway Clearance System (K031876) Phase IV Device Efficacy

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT04375514
Study type	Interventional
Source	Arrowhead Pharmaceuticals
Contact
Status	Terminated
Phase	Phase 1
Start date	August 10, 2020
Completion date	September 3, 2021

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms