← Back to all trials
Recruiting
NCT07227207
A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD)
Conditions: Alpha-1 Antitrypsin Deficiency (AATD)
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 72
Sponsor: Tessera Therapeutics, Inc.
Location: Clinical Study Center Jacksonville Florida
Summary
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)
Eligibility Criteria
Inclusion Criteria:
* 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 \
Source: ClinicalTrials.gov (NCT07227207). StuddyBuddy aggregates publicly available trial information.