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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-05-31

Brief Summary

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

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Detailed Description

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Conditions

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TTR-mediated Amyloidosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ALN-TTRSC (revusiran)

Group Type ACTIVE_COMPARATOR

ALN-TTRSC (revusiran)

Intervention Type DRUG

Ascending doses of ALN-TTRSC (revusiran) by subcutaneous (SC) injection

Sterile Normal Saline (0.9% NaCl)

Group Type PLACEBO_COMPARATOR

Sterile Normal Saline (0.9% NaCl)

Intervention Type DRUG

Calculated volume to match active comparator

Interventions

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ALN-TTRSC (revusiran)

Ascending doses of ALN-TTRSC (revusiran) by subcutaneous (SC) injection

Intervention Type DRUG

Sterile Normal Saline (0.9% NaCl)

Calculated volume to match active comparator

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes