Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer Subjects

A Phase 1, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-TTR02 in Healthy Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR02 in healthy volunteer subjects.

Inclusion Criteria:

• Body mass index must be between 18.0 kg/m2 and ≤ 31.5 kg/m2;
• Non-smokers for at least 3 months preceding screening;
• Females subjects must be of non-childbearing potential e.g., post-menopausal or pre-menopausal with surgical sterilization;
• Males agree to use appropriate contraception;
• Medical history must be verified by either a personal physician or medical practitioner as appropriate;
• Willing to give written informed consent and are willing to comply with the study requirements.

Exclusion Criteria:

• Known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection
• Multiple drug allergies or know sensitivity to oligonucleotide
• History of drug abuse and/or alcohol abuse
• Receiving an investigational agent within 3 months prior to study drug administration
• Subjects with safety laboratory test results deemed clinical significant by the Investigator;
• Received prescription drugs within 4 weeks of first dosing
• Subjects who have donated more than 500 mL of blood within the 3 months prior to ALN-PCS02 or placebo administration;
• Subjects who have used prescription drugs within 4 weeks of first dosing
• Considered unfit for the study by the Principal Investigator
• Employee or family member of the sponsor or the clinical study site personnel