ClinicaliQ Trial Snapshot
- A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD) — Recruiting • Phase I • Respiratory / COPD / Asthma • NCT07227207.
- TSRA-196 is being tested as a potential therapeutic intervention in adults with PiZZ alpha-1 antitrypsin deficiency (AATD), a serious genetic disorder causing progressive lung and liver disease, evaluated across dose escalation, expansion, and repeat dosing phases to establish safety and efficacy profiles.
- Eligible patients are adults with confirmed PiZZ genotype AATD, enrolled across multiple centres in a structured trial design progressing from initial safety assessment through dose optimisation and repeat administration to determine tolerability thresholds and pharmacokinetic/pharmacodynamic responses.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.