RecruitingAlpha-1 Antitrypsin Deficiency (AATD)
A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD)
Eligible age
18–70 yrs
Accepts
All genders
Locations
5 states
Healthy volunteers
No
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About this study
This is a Phase 1/2, open-label, multi-center, dose escalation (Part 1), dose expansion (Part 2), and single repeat dose (Part 3) study to evaluate the safety, tolerability, efficacy, and PK/PD parameters of TSRA-196 in adults with the PiZZ genotype who have lung and/or liver disease associated with severe alpha-1 antitrypsin deficiency (AATD)
Sponsor: Tessera Therapeutics, Inc.
You may qualify if…
- ✓ Males or females who are 18 to 70 years of age, inclusive, at the time of signing the informed consent
- ✓ Body mass index of 18 to 37 kg/m2, inclusive
- ✓ Confirmed diagnosis of AATD and PiZZ genotype
- ✓ At least one previous measure of blood total AAT level \<11 µmol/L
- ✓ Nonsmoker for at least 6 months before screening and must remain nonsmoking for the entire study duration
- ✓ Either AAT treatment-naïve or washed out of all investigational or approved treatments that modify AAT levels for 5 half-lives or at least 4 weeks, whichever is longer, before TSRA-196 administration
- ✓ Parts 1A and 2A (AATD lung disease with no or minimal liver fibrosis)
- ✓ Clinically significant lung disease, defined as 1) evidence of emphysema or bronchiectasis by computed tomography or 2) DLCO \<70% of the predicted value or 3) ppFEV1 \<80%
You may not qualify if…
- ✕ Presence of genetic variation in SERPINA1 gene that may disrupt the function of TSRA-196, determined by screening genotyping
- ✕ History of liver disease unrelated to AATD, or history of or clinical signs of cirrhosis
- ✕ Significant lung disease not attributable to manifestations of AATD, as determined by the investigator
- ✕ History of one or more hospitalizations due to severe exacerbation of underlying lung disease during the year before screening or received IV antibiotics for treatment of a pulmonary infection within 6 months before screening
- ✕ Unstable AATD-related COPD, as determined by the investigator, or severe bronchiectasis
- ✕ Lung volume reduction surgery within 1 year before screening or plan to receive lung volume reduction surgery during the study period
- ✕ Documented chronic need for positive airway pressure therapy beyond nocturnal use
- ✕ Seropositive for human immunodeficiency virus (HIV) (HIV-1 or HIV-2)
Where it's recruiting
Source: ClinicalTrials.gov · NCT07227207 · last updated 2026-09-24