Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA (LIBERATEI)

A Phase 1a/b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of NTR-1011 in Healthy Adults and Adult Patients With Systemic Lupus Erythematosus (SLE) and Rheumatoid Arthritis (RA)

This phase 1a and 1b study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of NTR-1011 in healthy adults and in adult patients with systemic lupus erythematosus and rheumatoid arthritis. The main goals of this study are to determine the safety profile of NTR-1011 across subcutaneous and intravenous dose levels, understand how the drug behaves in the body, characterize its biological activity through relevant pharmacodynamic markers, assess the potential for immune responses to treatment, and explore early signals of clinical benefit in autoimmune disease settings.

This is a randomized, double blind, placebo controlled study that begins with a single ascending dose evaluation in healthy volunteers followed by a multiple dose assessment in patients. The design is intended to define the highest safe and well tolerated dose, establish a robust PK and PD baseline, and generate initial patient level evidence to support dose selection and advancement into subsequent clinical development.

Study Overview

• Status: Completed
• Conditions: RA - Rheumatoid Arthritis; SLE (Systemic Lupus)
• Intervention / Treatment: Drug: NTR1011

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • California Clinical Trials Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

1. Healthy males and females between 18 and 55 years of age.
2. Body mass index between 17.0 and 30.0 kg/m2.
3. Healthy with no clinically significant findings, as determined by medical evaluation (medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations) at Screening Visit.
4. Participant voluntarily agrees to participate in this study and signs an Ethics Committee (EC) approved informed consent form (ICF) prior to performing any of the Screening Visit procedures.
5. Participant can understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.

Exclusion Criteria:

1. Pregnancy, nursing, and/or breastfeeding.
2. The participant has used an investigational drug within 30 days (or 5 half-lives whichever is longer) before the first dose of the study intervention.

2. Has received any prescription or nonprescription over the counter (except occasional use of acetaminophen, paracetamol, or ibuprofen prior to dosing) medication during the last 14 days. Occasional use is defined at the Investigator's discretion.

3. Has a positive urine test for drugs of abuse, or cotinine at the Screening Visit, regular consumption of alcohol within 6 months before screening or use of illicit substances within 3 months before the Screening Visit.

4. Has a positive test for hepatitis B surface antigen, hepatitis C virus and/or human immunodeficiency virus (HIV).

5. Donation or loss of blood or plasma within 4 weeks before initial dosing.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low dose SC NHV; Lowest subcutaneous dosage in normal healthy volunteers	Drug: NTR1011; NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Experimental: Mid dose SC NHV; middle subcutaneous dosage in normal healthy volunteers	Drug: NTR1011; NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Experimental: High dose SC NHV; Highest subcutaneous dosage SC in normal healthy volunteers	Drug: NTR1011; NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Experimental: Low dose IV NHV; lowest intravenous dosage in normal healthy volunteers	Drug: NTR1011; NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Experimental: Mid dose IV NHV; middle intravenous dosage in normal healthy volunteers	Drug: NTR1011; NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Experimental: High dose IV NHV; highest intravenous dosage in normal healthy volunteers	Drug: NTR1011; NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Placebo Comparator: Placebo, IV; 0 mg/kg, IV NHV	Drug: NTR1011; NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Placebo Comparator: Placebo, SC; 0 mg/kg, SC NHV	Drug: NTR1011; NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Incidence of safety and tolerability (DLTs) to inform RP2D	30 days

Collaborators and Investigators

• Sponsor: Neutrolis
• Investigators: Study Chair: Andreas Reiff, PhD, MD, Neutrolis; Principal Investigator: Hakop Gevorkyan, MD, California Clinical Trials Medical Group

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2025
• Primary Completion (Actual): February 17, 2026
• Study Completion (Actual): February 17, 2026

Study Registration Dates

• First Submitted: November 12, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: LIBERATE I; Neutrolis; DNase1L3 fusion protein; DNase1L3 analogue
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Arthritis, Rheumatoid
• Other Study ID Numbers: NTR1011-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No value outside of this trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No