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Keep this study
Lead
Arrowhead Pharmaceuticals
Participants will be enrolled to receive multiple subcutaneous injections of Fazirsiran Injection (also referred to as TAK-999 Injection or ARO-AAT Injection) or placebo. Eligible participants will require a pre-dose biopsy completed as part of the study within the screening window. However, any participant with a biopsy result within 1 year of screening showing no fibrosis does not require a pre-dose biopsy. Only participants who have liver fibrosis will undergo a post-dose biopsy and may continue treatment in an open-label phase.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of AATD
Liver biopsy at Screening indicating liver fibrosis (score less than F4); a patient with no fibrosis may participate based on a previous biopsy conducted within one year
Women of childbearing 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 1 year
No abnormal finding of clinical relevance at Screening
You may not be if
Clinically significant health concerns other than AATD
Previous diagnosis or diagnosis at Screening of definitive liver cirrhosis
Previous lung or liver transplant due to AATD
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 involving therapeutic intervention
Use of illicit drugs within 1 year prior to Screening
Clareo Health | Safety, Tolerability and Pharmacodynamic Effect of Fazirsiran (TAK-999, ARO-AAT)
