NCT02053454

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-TTR02 in Japanese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	patisiran (ALN-TTR02)	Ascending doses administered by intravenous (IV) infusion
DRUG	Sterile Normal Saline (0.9% NaCl)	Calculated volume to match active comparator

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-03-01
• Completion: 2014-06-01
• First posted: 2014-02-03
• Last updated: 2015-05-25

Locations

1 site across 1 country: United Kingdom