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

NCT02053454 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2015-05-25

No results posted yet for this study

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

Interventions

DRUG

patisiran (ALN-TTR02)

Ascending doses administered 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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • 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 NCT02053454 on ClinicalTrials.gov