NTR-1011 / Neutrolis - LARVOL DELTA

First-in-Human Safety, Tolerability, Pharmacokinetics, and Immunogenicity of NTR-1011, a Recombinant DNASE1L3-Albumin Fusion Protein for Subcutaneous Delivery: Results from a Phase 1 Single Ascending Dose Study in Healthy Volunteers (ACR Convergence 2026) - No abstract available

Clinical • First-in-human • P1 data • PK/PD data • Immunology • Lupus • Systemic Lupus Erythematosus • DNASE1L3

LIBERATEI: Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Neutrolis | Completed ➔ Recruiting | N=36 ➔ 24 | Trial completion date: Feb 2026 ➔ Aug 2027 | Initiation date: Sep 2025 ➔ Jul 2026 | Trial primary completion date: Feb 2026 ➔ Mar 2027

Enrollment change • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

LIBERATEI: Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Neutrolis | Recruiting ➔ Completed

Trial completion • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus

Neutrolis Announces Positive First-in-Human Phase 1a Results from LIBERATE-I Trial of NTR-1011, a First-in-Class DNASE1L3 Fusion Protein (GlobeNewswire) - "NTR-1011 demonstrated a favorable safety, tolerability, and immunogenicity profile across multiple dose levels of intravenous (IV) and subcutaneous (SC) administrations. NTR-1011 displayed a predictable pharmacokinetic (PK) profile with robust SC bioavailability supporting future chronic SC dosing. The LIBERATE-I Phase 1b trial in patients with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) will be initiated mid-2026."

P1 data • Trial status • Rheumatoid Arthritis • Systemic Lupus Erythematosus

LIBERATEI: Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Neutrolis

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Rheumatoid Arthritis • Rheumatology • Systemic Lupus Erythematosus