[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tessera Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100610409","phase-1-a-study-of-tsra-196-in-adults-with-pizz-alpha-1-antitrypsin-deficiency-aatd-100610409",false,"NCT07227207","A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD)","A Phase 1\u002F2, Open-Label, Multi-Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA-196 in Adults With the PiZZ Genotype Who Have Lung and\u002For Liver Disease Associated With Severe Alpha-1 Antitrypsin Deficiency","Inclusion Criteria:\n\n* Males or females who are 18 to 70 years of age, inclusive, at the time of signing the informed consent\n* Body mass index of 18 to 37 kg\u002Fm2, inclusive\n* Confirmed diagnosis of AATD and PiZZ genotype\n* At least one previous measure of blood total AAT level \\\u003C11 µmol\u002FL\n* Nonsmoker for at least 6 months before screening and must remain nonsmoking for the entire study duration\n* 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\n\nParts 1A and 2A (AATD lung disease with no or minimal liver fibrosis)\n\n* Clinically significant lung disease, defined as 1) evidence of emphysema or bronchiectasis by computed tomography or 2) DLCO \\\u003C70% of the predicted value or 3) ppFEV1 \\\u003C80%\n* ppFEV1 ≥35%\n* METAVIR fibrosis score F0 or F1 confirmed by liver biopsy at screening, or a liver stiffness measure by FibroScan ≤7 kPa at screening\n* FIB-4 index score ≤3.25 at screening\n* ALT and\u002For AST \\\u003CULN at screening\n\nParts 1B and 2B (AATD liver disease with significant or severe liver fibrosis, with or without AATD lung disease)\n\n* METAVIR fibrosis score F2 or F3 confirmed by liver biopsy at screening. A liver biopsy conducted within 12 months before screening is acceptable as a substitute.\n* Liver stiffness measure by FibroScan \\>7 and ≤15 kPa at screening\n* ALT and\u002For AST \\\u003C2 x ULN at screening\n\nExclusion Criteria:\n\n* Presence of genetic variation in SERPINA1 gene that may disrupt the function of TSRA-196, determined by screening genotyping\n* History of liver disease unrelated to AATD, or history of or clinical signs of cirrhosis\n* Significant lung disease not attributable to manifestations of AATD, as determined by the investigator\n* 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\n* Unstable AATD-related COPD, as determined by the investigator, or severe bronchiectasis\n* Lung volume reduction surgery within 1 year before screening or plan to receive lung volume reduction surgery during the study period\n* Documented chronic need for positive airway pressure therapy beyond nocturnal use\n* Seropositive for human immunodeficiency virus (HIV) (HIV-1 or HIV-2)\n* Seropositive for hepatitis B (hepatitis B surface antigen \\[HBsAg\\] or hepatitis B core antibody \\[HBcAb\\] positive) with detectable HBV DNA\n* Hepatitis C virus (HCV) RNA positive at screening (Parts 1A and 2A), or HCV RNA positive and\u002For HCV antibody positive at screening (Parts 1B and 2B)\n* Has received an organ transplant or is on a waiting list for an organ transplant\n* Prior treatment with gene therapy using viral vectors or intended to permanently change the patient's DNA\n* Any investigational products within 30 days before dosing or plan to take an investigational product before the end of study","ALL","18 Years","70 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a Phase 1\u002F2, 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\u002FPD parameters of TSRA-196 in adults with the PiZZ genotype who have lung and\u002For liver disease associated with severe alpha-1 antitrypsin deficiency (AATD)",[28],"Alpha-1 Antitrypsin Deficiency (AATD)","RECRUITING","2026-05-13",{"date":32,"type":33},"2026-05-18","ACTUAL",{"date":35,"type":33},"2026-04-21",{"date":37,"type":21},"2029-03",{"name":39,"class":40},"Tessera Therapeutics, Inc.","INDUSTRY",3,""]