The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitrypsin Deficiency (AATD).
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of Participants With Adverse Events (AEs)
Timeframe: Up to 668 days
Number of Participants With Suspected Adverse Drug Reactions (ADRs)
Timeframe: Up to 668 days
Number of Participants With Infusion Site Reactions
Timeframe: Up to 668 days
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Up to 668 days
Number of Participants With AEs and SAEs Leading to Discontinuation
Timeframe: Up to 668 days
Number of Participants With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Timeframe: Up to 668 days
Number of Participants With Clinically Significant Abnormalities in Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate, and Temperature)
Timeframe: Up to 668 days
Change from Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Timeframe: Up to 668 days
Change from Baseline in Forced Vital Capacity (FVC)
Timeframe: Up to 668 days
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters (Chemistry, Hematology, Urinalysis)
Timeframe: Up to 668 days
Immunogenicity: Number of Participants With Alpha1-PI Antibodies
Timeframe: Treatment Period 1- Single-Dose Week 1; Treatment Period 2- Repeat-Dose Weeks 1 and 9