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A Study of ALN-AAT02 in Healthy Participants and Participants With ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease

NCT03767829 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-04-27

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of single or multiple doses of ALN-AAT02. The study will be conducted in 2 sequential phases in which Part A will be a single-ascending dose (SAD) phase in healthy participants, and Part B will be a multiple-ascending dose (MAD) phase in participants with ZZ type alpha-1 antitrypsin deficiency (PiZZ) and biopsy-proven alpha-1 antitrypsin (AAT) deficiency-associated liver disease.

Conditions

  • ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease

Interventions

DRUG

ALN-AAT02

ALN-AAT02 will be administered subcutaneously (SC) at dose levels planned for Part A.

DRUG

Placebo

Sterile normal saline (0.9% NaCl) matching volume of ALN-AAT02 doses will be administered SC.

DRUG

ALN-AAT02

ALN-AAT02 will be administered subcutaneously (SC). Part B dose levels to be determined upon review of data from Part A.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Alnylam Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2020-06-25
Completion
2020-06-25

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT03767829 on ClinicalTrials.gov