Study Details
Testing the Drug INBRX-101 in Adults with AATD Emphysema
(IRB#: IRB_00169660)
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 in this study will be placed into two groups. Group 1 will receive INBRX-101. Group 2 will receive Zemaira. Being in the study requires attendance at the study center for up to 51 weeks once a week to receive treatment with either INBRX-101 or Zemaira. 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
- 18 to 80 years of age
- Diagnosis of Alpha-1 Antitrypsin Deficiency (AATD)
- Evidence of emphysema secondary to AATD
- Current non-smoking status and must commit to remain non-smoking for the entire study duration
Exclusion Criteria
- Had Plasma Derived Alpha1-Proteinase Inhibitor (A1P1) augmentation therapy within 5 weeks prior to study
- Suspected or diagnosed with Type 1 diabetes, or diagnosed with uncontrolled Type 2 diabetes, or have a current A1c >/= 9.0
- Participation in another investigational drug study 30 days prior to study
- Females who are pregnant or breastfeeding or females of childbearing potential unwilling to practice effective birth control during the study
Will I be paid for my time?
Yes
IRB#: IRB_00169660
PI: Cheryl Pirozzi
Department: PULMONARY
Approval Date: 2023-10-04 06:00:00
Specialties: Pulmonary