Study Details
Testing the Drug INBRX-101 in Adults with AATD Emphysema
(IRB#: IRB_00179012)
AADT emphysema is a disorder where too much air collects deep in the lungs that is caused by the lack of a protein called alpha-1 antitrypsin (AAT) in the body. A deficiency of AAT (AATD) can damage the lungs and liver if not treated. The study will test a drug called INBRX-101 to treat adults with this disease. The study wants to see if the drug will help people with the disease and is safe. People who have recently finished the INBRX phase 2 study and would like to continue taking INBRX-101 are invited to participate, as well as people who are new to this study. Being in the study requires attendance at the study center for up to 3 years every 3 weeks to receive treatment with INBRX-101. Other study visits will be required for medical tests to track the health of participants.
- All genders
- Over 18 years old
- Volunteers with special conditions
- In Person
- Paid
Who can participate?
Gender: All genders
Age: Over 18 years old
Volunteers: Volunteers with special conditions
Location: In Person
Inclusion Criteria
- Ages 18 to 80 years old
- Diagnosis of Alpha-1 Antitrypsin Deficiency (AATD)
- Evidence of emphysema secondary to Alpha-1 Antitrypsin Deficiency (AATD)
- Currently non-smoking and must commit to remaining non-smoking during the entire study
- Fully participate
Exclusion Criteria
- Received Alpha-1 Proteinase Inhibitor (A1PI) therapy within 5 weeks before the first dose of INBRX-101
- Known selective or severe IgA deficiency.
- Known or possible diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
- Participation in any clinical study within 30 days before the first dose of INBRX-101
- Received specific therapies to fight infections and diseases such as intravenous immunoglobulins, and monoclonal antibodies for 30 days before the first dose of INBRX-101
Will I be paid for my time?
Yes
IRB#: IRB_00179012
PI: Cheryl Pirozzi
Department: PULMONARY
Approval Date: 2024-08-28 06:00:00
Specialties: Pulmonary