NCT03815396

Phase 1 Study to Assess the Safety, PK and PD of INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency

An Open-Label, Multicenter, Phase 1 Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Intravenous Doses of Inhibrx rhAAT-Fc (INBRX-101) in Adults With Alpha-1 Antitrypsin Deficiency (AATD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Inhibrx Biosciences, Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alpha-1 Antitrypsin Deficiency
• AATD

Interventions

Type	Name	Description
DRUG	INBRX-101/rhAAT-Fc	INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).

Timeline

• Start date: 2019-07-19
• Primary completion: 2022-08-18
• Completion: 2022-08-18
• First posted: 2019-01-24
• Last updated: 2022-09-13

Locations

10 sites across 3 countries: United States, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study