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

Alnylam Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

TTR-mediated Amyloidosis

Treatments

Drug: ALN-TTR02

Drug: Sterile Normal Saline (0.9% NaCl)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01559077

ALN-TTR02-001

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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