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

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Contents

clinicaltrials.gov/study/NCT04375514
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT043755140
Trial Recruitment Size
430
Trial Sponsor
Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals
0
Clinical Trial Start Date
August 10, 2020
0
Primary Completion Date
September 3, 2021
0
Study Completion Date
September 3, 2021
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Intervention Name
ARO-ENaC0
Placebo0
Interventional Trial Phase
Phase 10
Official Name
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-ENaC in Normal Healthy Volunteers and Safety, Tolerability and Efficacy in Patients With Cystic Fibrosis0
Last Updated
October 24, 2022
0
Allocation Type
Randomized0
Intervention Model
Sequential Assignment0
Masking Type
Quadruple0
Masked Party
Investigator0
Care Provider0
Participant0
Outcomes Assessor0
Study 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.

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