NCT02797847

A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy Subjects

A Phase 1, Randomized, Single-Blind, Placebo Controlled, Single-Ascending Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-TTRSC02 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC02 in healthy subjects.

Conditions

• Transthyretin-mediated Amyloidosis (ATTR Amyloidosis)

Interventions

Type	Name	Description
DRUG	ALN-TTRSC02	Ascending doses of ALN-TTRSC02 by subcutaneous (SC) injection
DRUG	Sterile Normal Saline (0.9% NaCl)	Calculated volume to match active comparator

Timeline

• Start date: 2016-06-07
• Primary completion: 2018-01-12
• Completion: 2018-01-12
• First posted: 2016-06-14
• Last updated: 2018-09-21

Locations

1 site across 1 country: United Kingdom