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A Phase 1/2, 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/or Liver Disease Associated With Severe Alpha-1 Antitrypsin Deficiency

Trial Profile

A Phase 1/2, 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/or Liver Disease Associated With Severe Alpha-1 Antitrypsin Deficiency

Status: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 Jan 2026

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At a glance

  • Drugs TSRA 196 (Primary)
  • Indications Alpha 1-antitrypsin deficiency; Bronchiectasis; Emphysema; Hepatic fibrosis
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors Tessera Therapeutics

Most Recent Events

  • 12 Jan 2026 According to a Tessera Therapeutics, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TSRA-196, for alpha-1 antitrypsin deficiency (AATD). The Company has also received Australian Human Research Ethics Committee (HREC) approval to begin the Phase 1/2 clinical trial.
  • 17 Nov 2025 New trial record

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