Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis

Inclusion Criteria:

- Body mass index must be between 17 kg/m^2 and ≤ 33 kg/m^2;

- Women of child-bearing potential must have a negative pregnancy test, cannot be breast
feeding, and must use appropriate contraception;

- Males agree to use appropriate contraception;

- Diagnosis of TTR amyloidosis;

- Adequate blood counts, liver and renal function;

- Willing to give written informed consent and are willing to comply with the study
requirements.

Exclusion Criteria:

- Known human immunodeficiency virus (HIV) positive status or known or suspected
systemic bacterial, viral, parasitic, or fungal infection;

- Received an investigational agent, other than tafamidis or diflunisal, within 30 days
prior to first dose study drug administration;

- Prior liver transplant;

- Poor cardiac function;

- Considered unfit for the study by the Principal Investigator;

- Employee or family member of the sponsor or the clinical study site personnel.