NCT04722887View on ClinicalTrials.gov

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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

August 13, 2021

Primary Completion Date

July 17, 2025

Study Completion Date

July 17, 2025

Conditions
Alpha1-Antitrypsin Deficiency
Interventions
BIOLOGICAL

Alpha-1 15%

Alpha1-Proteinase Inhibitor (Human), 15%, Subcutaneous infusion

BIOLOGICAL

Liquid Alpha1-Proteinase Inhibitor (Human)

Intravenous infusion

Trial Locations (6)

29425

Medical University of South Carolina - Children's Hospital, Charleston

32610

University of Florida, Gainesville

33136

University of Miami, Miami

44195

Cleveland Clinic, Cleveland

85013

Dignity Health-St. Joseph's Hospital & Medical Center, Phoenix

90025

UCLA Medical Center, Los Angeles

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY

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 | Biotech Hunter | Biotech Hunter