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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

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