NCT03815396 (rhAAT-Fc) is a Phase 1 clinical trial of INBRX-101/rhAAT-Fc in Alpha-1 Antitrypsin Deficiency, sponsored by Inhibrx Biosciences, Inc.

Who is sponsoring NCT03815396?

NCT03815396 is sponsored by Inhibrx Biosciences, Inc.

What drugs are being tested in NCT03815396?

Interventions in NCT03815396: INBRX-101/rhAAT-Fc.

What condition does NCT03815396 study?

NCT03815396 studies Alpha-1 Antitrypsin Deficiency, AATD.

Is NCT03815396 still recruiting?

NCT03815396 is currently completed. Last updated 13 September 2022.

Last reviewed 2022-09-13 · How we verify

NCT03815396: rhAAT-Fc

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 13 September 2022

What this trial tests

Phase 1 trial testing INBRX-101/rhAAT-Fc in Alpha-1 Antitrypsin Deficiency in 31 participants. Completed in 18 August 2022.

Timeline

19 July 2019

Primary endpoint
18 August 2022

18 August 2022

Quick facts

Lead sponsor	Inhibrx Biosciences, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	31
Start date	19 July 2019
Primary completion	18 August 2022
Estimated completion	18 August 2022
Sites	10 locations across New Zealand, United Kingdom, United States

Drugs / interventions tested

INBRX-101/rhAAT-Fc — full drug profile →

Conditions studied

Alpha-1 Antitrypsin Deficiency — all drugs for Alpha-1 Antitrypsin Deficiency →
AATD — all drugs for AATD →

Sponsor

Inhibrx Biosciences, Inc — full company profile →

Who can join

Adults 18 to 80, any sex, with Alpha-1 Antitrypsin Deficiency or AATD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Novel Anti-Inflammatory Approaches to COPD.
Cazzola M, Hanania NA, Page CP, Matera MG. · · 2023 · cited 42× · PMID 37408603 · DOI 10.2147/copd.s419056
Therapeutic SERPINs: Improving on Nature.
Maas C, de Maat S. · · 2021 · cited 23× · PMID 33869308 · DOI 10.3389/fcvm.2021.648349
Gene therapy for alpha 1-antitrypsin deficiency with an oxidant-resistant human alpha 1-antitrypsin.
Sosulski ML, Stiles KM, Frenk EZ, Hart FM, et al · · 2020 · cited 14× · PMID 32759494 · DOI 10.1172/jci.insight.135951
Recombinant Alpha-1 Antitrypsin-Fc Fusion Protein INBRX-101 in Adults With Alpha-1 Antitrypsin Deficiency: A Phase 1 Study.
Brantly ML, Kuhn BT, Farah HW, Mahadeva R, et al · · 2024 · cited 11× · PMID 38809792 · DOI 10.15326/jcopdf.2023.0469
Resolution Pharmacology: State-of-the-art and therapeutic landscape.
Perretti M, Montero-Melendez T. · · 2025 · cited 1× · PMID 41205263 · DOI 10.1016/j.pharmr.2025.100097
Proteomic Profiling of Protease-Primed Virus-Permissive Caco-2 Cells Display Abortive-Interferon Pathway and Deregulated Thromboinflammatory SERPINS
Sharma M, Panda NK. · · 2020 · DOI 10.20944/preprints202006.0206.v1

Verify or expand the search:

Other recruiting trials for Alpha-1 Antitrypsin Deficiency

Currently open trials in the same condition.

NCT01851642 — Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs · recruiting

Other Inhibrx Biosciences, Inc trials

Trials by the same sponsor.

NCT04198766 — Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Meta · Phase 1, PHASE2 · active not recruiting
NCT03809624 — Study of INBRX-105 and INBRX-105 With Pembrolizumab in Patients With Solid Tumors Including Head and Neck Cancer · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03815396 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inhibrx Biosciences, Inc
Last refreshed: 13 September 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03815396.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing