A Multi-Center, Single-Dose and Repeat-Dose Over Eight Weeks, Sequential Cohort Study to Evaluate Safety and Tolerability as Well as Pharmacokinetics of Two Different Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% Administered Subcutaneously in Subjects With Alpha1-Antitrypsin Deficiency
Latest Information Update: 01 Aug 2024
At a glance
- Drugs Alpha 1-antitrypsin (Primary) ; Alpha 1-antitrypsin
- Indications Alpha 1-antitrypsin deficiency
- Focus Adverse reactions; First in man; Pharmacodynamics; Therapeutic Use
- Sponsors Grifols
- 04 Dec 2023 Dose of Alpha-1 15% in cohort-2 increased from 144 to 180 mg/kg.
- 04 Dec 2023 Planned End Date changed from 23 Nov 2024 to 14 Mar 2025.
- 04 Dec 2023 Planned primary completion date changed from 23 Nov 2024 to 14 Mar 2025.