Study of ARO-AAT in Normal Adult Volunteers

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Brief Title

Study of ARO-AAT in Normal Adult Volunteers

Official Title

A Phase 1 Single and Multiple Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect of ARO-AAT on Serum Alpha-1 Antitrypsin Levels in Normal Adult Volunteers

Brief Summary

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Number of Participants With Adverse Events (AEs) Possibly or Probably Related to Treatment

Secondary Outcome

 Pharmacokinetics (PK) of ARO-AAT: Maximum Observed Plasma Concentration (Cmax)

Condition

Alpha 1-Antitrypsin Deficiency

Intervention

ARO-AAT Injection

Study Arms / Comparison Groups

 ARO-AAT
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

45

Start Date

March 12, 2018

Completion Date

June 30, 2020

Primary Completion Date

October 11, 2018

Eligibility Criteria

        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

        NOTE: additional inclusion/exclusion criteria may apply, per protocol
      

Gender

All

Ages

18 Years - 55 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

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Location Countries

New Zealand

Location Countries

New Zealand

Administrative Informations


NCT ID

NCT03362242

Organization ID

AROAAT1001


Responsible Party

Sponsor

Study Sponsor

Arrowhead Pharmaceuticals


Study Sponsor

, , 


Verification Date

January 2020