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

Alnylam Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Transthyretin (TTR)-Mediated Amyloidosis

Treatments

Drug: Sterile Normal Saline (0.9% NaCl)

Drug: patisiran (ALN-TTR02)

Study type

Interventional

Funder types

Industry

Identifiers

ALN-TTR02-005

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.