drugset / Trial / NCT04722887
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Participants With Alpha1-Antitrypsin Deficiency
Non-randomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability of 72 milligrams per kilogram (mg/kg) and 180 mg/kg Alpha-1 15%, administered as a single-dose subcutaneous (SC) infusion and subsequently as weekly SC infusions over 8 weeks in participants with Alpha1-Antitrypsin Deficiency (AATD).
Timeline
- Start
- 2021-08-13
- Primary completion
- 2025-08-01
- Completion
- 2025-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 60 mg/kg | Intravenous |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 72 mg/kg | Subcutaneous |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 120 mg/kg | Intravenous |
| Subject | Alpha 1-Antitrypsin | Protein / enzyme biologic | 180 mg/kg | Subcutaneous |