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

NCT ID: NCT02053454

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-06-30

Brief Summary

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

Conditions

Transthyretin (TTR)-Mediated Amyloidosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

patisiran (ALN-TTR02)

Group Type: ACTIVE_COMPARATOR

patisiran (ALN-TTR02)

Intervention Type: DRUG

Ascending doses administered by intravenous (IV) infusion

Sterile Normal Saline (0.9% NaCl)

Group Type: ACTIVE_COMPARATOR

Sterile Normal Saline (0.9% NaCl)

Intervention Type: DRUG

Calculated volume to match active comparator

Interventions

patisiran (ALN-TTR02)

Ascending doses administered by intravenous (IV) infusion

Intervention Type: DRUG

Sterile Normal Saline (0.9% NaCl)

Calculated volume to match active comparator

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alnylam Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jared Gollob, MD

Role: STUDY_DIRECTOR

Alnylam Pharmaceuticals

Locations

Clinical Site

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

ALN-TTR02-005

Identifier Type: -

Identifier Source: org_study_id