Status:
COMPLETED
Study of ARO-AAT in Normal Adult Volunteers
Lead Sponsor:
Arrowhead Pharmaceuticals
Conditions:
Alpha 1-Antitrypsin Deficiency
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 21 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03362242
Start Date
March 12 2018
End Date
March 21 2020
Last Update
December 24 2025
Active Locations (1)
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1
Research Site 1
Grafton, Auckland, New Zealand, 1010