A Study of the Safety, Tolerability and Pharmacokinetics of ALN-TTR02 in Japanese Healthy Volunteers

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of patisiran (ALN-TTR02) in Japanese subjects

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

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

Inclusion Criteria:

• Healthy Japanese adult males and females aged 20 to 65 years, inclusive (The subject was born in Japan and has lived outside of Japan for <10 years, and subject's biological parents and grandparents are fully Japanese and were born in Japan);

• Subjects who are healthy as determined by clinical assessments;

• Females subjects must be of non-childbearing potential;

• Males with partners of child-bearing potential, must agree to use appropriate contraception.

Exclusion Criteria:

• Subjects with a history of serious mental illness;

• Subjects who have a clinically relevant medical or surgical history;

• Subjects with a positive screen for alcohol or drugs of abuse;

• Subjects with safety laboratory test results deemed clinically significant;

• Subjects with known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection;

• Subjects who have received an investigational agent within the 3 months prior to study entry.