drugset / Trial / NCT03815396
Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency
Non-randomizedSequentialOpen-labelTreatment
Summary
This is an open-label, 2-part, dose-escalating, Phase 1 study of INBRX-101 (rhAAT-Fc). Part 1 will consist of single ascending dose (SAD) administration of INBRX-101 and Part 2 will consist of multiple ascending dose (MAD) administrations of INBRX-101. The planned dosing schedule is IV every 3 to 4 weeks.
Timeline
- Start
- 2019-07-19
- Primary completion
- 2022-08-18
- Completion
- 2022-08-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INBRX-101 | Protein / enzyme biologic | — | Intravenous |