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Study of ARO-AAT in Normal Adult Volunteers

NCT ID: NCT03362242

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2020-03-21

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-AAT in healthy adult volunteers.

Detailed Description

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Conditions

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Alpha 1-Antitrypsin Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ARO-AAT

Group Type ACTIVE_COMPARATOR

ARO-AAT Injection

Intervention Type DRUG

Single or multiple doses of ARO-AAT by subcutaneous (sc) injections

Placebo

Group Type PLACEBO_COMPARATOR

Sterile Normal Saline (0.9% NaCl)

Intervention Type OTHER

Calculated volume to match active comparator

Interventions

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ARO-AAT Injection

Single or multiple doses of ARO-AAT by subcutaneous (sc) injections

Intervention Type DRUG

Sterile Normal Saline (0.9% NaCl)

Calculated volume to match active comparator

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Women of child bearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception
* Willing to provide written informed consent and to comply with study requirements
* Non-smoker for at least one year
* Normal lung function
* No abnormal finding of clinical relevance at Screening
* Normal AAT level at Screening visit

Exclusion Criteria

* Clinically significant health concerns
* Regular use of alcohol within one month prior to Screening
* Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study
* Recent use of illicit drugs
* Use of any drugs or dietary/herbal supplements know to interfere with liver metabolism
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arrowhead Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site 1

Grafton, Auckland, New Zealand

Site Status

Countries

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New Zealand

Other Identifiers

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AROAAT1001

Identifier Type: -

Identifier Source: org_study_id