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Trial to Evaluate Safety and Tolerability of ALN-TTR01 in Transthyretin (TTR) Amyloidosis

NCT01148953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-05-24

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR01 in patients with transthyretin (TTR) mediated amyloidosis (ATTR).

Conditions

  • Transthyretin Mediated Amyloidosis (ATTR)

Interventions

DRUG

ALN-TTR01

Dose levels between 0.01 and 1.0 mg/kg by intravenous (IV) infusion

DRUG

Sterile Normal Saline (0.9% NaCl)

Calculated volume to match active comparator

Sponsors & Collaborators

Principal Investigators

  • Jared Gollob, MD · Alnylam Pharmaceuticals Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-01-31
Completion
2012-02-29

Countries

  • France
  • Portugal
  • Sweden
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01148953 on ClinicalTrials.gov