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

NCT02503683 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2019-01-07

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Patrick Haslett, MD · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-09
Primary Completion
2018-01-03
Completion
2018-01-03

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 NCT02503683 on ClinicalTrials.gov