NCT02503683

A Study of an Investigational Drug, ALN-AAT, in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease

A Phase 1/2, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose, Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Alnylam Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients with ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease.

Conditions

• Antitrypsin Deficiency Liver Disease

Interventions

Type	Name	Description
DRUG	ALN-AAT	Single or multiple doses of ALN-AAT by subcutaneous (sc) injection
DRUG	Sterile Normal Saline (0.9% NaCl)	calculated volume to match active comparator

Timeline

• Start date: 2015-07-09
• Primary completion: 2018-01-03
• Completion: 2018-01-03
• First posted: 2015-07-21
• Last updated: 2019-01-07

Locations

1 site across 1 country: United Kingdom