An Open-Label, Multicenter, Phase 1 Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Intravenous Doses of Inhibrx rhAAT-Fc (INBRX-101) in Adults with Alpha-1 Antitrypsin Deficiency (AATD)
Study on Safety and Tolerability of Investigational Medication for Alpha-1 Antitrypsin Deficiency (AATD)
Brief description of study.
The purpose of the study is to assess safety and tolerability of a Phase I drug, INBRX-101 in patients with alpha-1 antitrypsin deficiency (AATD).
Detailed description of study
Here at IU Health, we are recruiting for clinical trial to study the effects of a new drug on Alpha-1 Antitrypsin Deficiency (AATD). All study procedures will take place at University Hospital at no cost to you. You will be compensated for your time and effort.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Alpha-1 Antitrypsin Deficiency (AATD)
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Age: 18 years - 70 years
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Gender: All
Inclusion Criteria
AATD diagnosis, willing to undergo 2 bronchoscopies
Non-smoker
Willing to hold current AATD treatment until study ends (about 5 months).
This study investigates the safety and tolerability of an investigational medication in patients with Alpha-1 Antitrypsin Deficiency (AATD). AATD is a genetic condition that can cause lung and liver problems. The purpose of this study is to understand how the investigational medication affects individuals with this condition.
Participants will undergo procedures such as bronchoscopies, which involve using a thin tube to look inside the lungs. All study procedures will take place at University Hospital, and participants will receive compensation for their time and effort.
- Who can participate: Adults diagnosed with Alpha-1 Antitrypsin Deficiency who are non-smokers and willing to undergo 2 bronchoscopies can participate. Participants must be willing to pause their current AATD treatment for about 5 months.
- Study details: Participants will take part in study procedures at University Hospital, including undergoing bronchoscopies. A bronchoscopy is a procedure that uses a thin tube to examine the lungs. Participants will be compensated for their time and effort.