A Phase 1, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-TTRSC (Revusiran) in Healthy Volunteers

• Status: Completed
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC (revusiran) in healthy volunteer subjects.

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

Details

• Lead Sponsor: Alnylam Pharmaceuticals

Criteria

Inclusion Criteria:

• Body mass index (BMI) must be ≥ 16.5 kg/m2 and ≤ 35.0 kg/m2;

• Female subjects must be of non-childbearing potential; e.g., postmenopausal or pre-menopausal with surgical sterilization;

• Male subjects agree to use appropriate contraception;

• Adequate blood counts, liver and renal function;

• Non-smokers for at least 3 months;

• Willing to give written informed consent and are willing to comply with the study requirements;

• 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 (cohorts 19 and 20).

Exclusion Criteria:

• Known human immunodeficiency virus (HIV) positive status or known or suspected systemic bacterial, viral, parasitic, or fungal infection;

• Subjects with a history of multiple drug allergies or intolerance to SC injection;

• History of drug abuse and/or alcohol abuse;

• Receiving an investigational agent within 3 months prior to study drug administration;

• Considered unfit for the study by the Principal Investigator.