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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 May 2024

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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
  • Most Recent Events

    • 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.
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