NCT01814839

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

A Phase 1, Randomized, Double-blind, Placebo-controlled, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-TTRSC in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• TTR-mediated Amyloidosis

Interventions

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

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2013-03-20
• Last updated: 2016-02-05

Locations

2 sites across 1 country: United Kingdom