Phase
Condition
Emphysema
Treatment
SAR447537
INBRX-101
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females 18-80 years of age, inclusive, at the time of screening
Diagnosis of AATD
Evidence of emphysema secondary to AATD
FEV1 of ≥ 30% predicted at screening and post-bronchodilator FEV1/FVC<0.7
Current non-smoking status
Exclusion
Exclusion Criteria:
Receipt of A1PI augmentation therapy within 5 weeks prior to the first dose of studydrug
Known or suspected allergy to components of SAR447537, A1PI or human IgG
Known or suspected diagnosis of type 1 diabetes or diagnosed with uncontrolled type 2 diabetes
Received IV immunoglobulins, monoclonal antibodies and/or other biologic therapieswithin 30 days
On waiting list for lung or liver transplant
Acute respiratory tract infection or COPD exacerbation within 4 weeks prior to orduring screening
Evidence of decompensated cirrhosis
Active cancers or has a history of malignancy within 5 years prior to screening
History of unstable cor pulmonale
Clinically significant congestive heart failure
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Lung Research Qld
Chermside, Queensland 4032
AustraliaActive - Recruiting
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