NTR-1011 for Lupus and Rheumatoid Arthritis

(LIBERATEI Trial)

Overseen By Ken Olivier, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Neutrolis

Must not be taking: Prescription medications

Disqualifiers: Pregnancy, Hepatitis, HIV, others

Compensation: Varies

Number of Visits: 2

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NTR-1011 for its effects on lupus and rheumatoid arthritis. The main goal is to determine if NTR-1011 is safe and how it behaves in the body, while also assessing any early benefits for these autoimmune conditions. Participants will receive the treatment through injections under the skin or into a vein, while some will receive a placebo (a treatment with no active drug). Those who are healthy and have no major health issues might be a good fit for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or nonprescription medications, except for occasional use of acetaminophen, paracetamol, or ibuprofen, at least 14 days before starting the trial.

Is there any evidence suggesting that NTR-1011 is likely to be safe for humans?

Research has shown that NTR-1011 is being tested for safety in treating autoimmune diseases like lupus and rheumatoid arthritis. The study explores how the drug works when administered in two ways: as a subcutaneous injection and intravenously. Early results suggest that targeting NETs (neutrophil extracellular traps, part of the immune system) might be a promising method for treating these conditions.

The study is in its early stages, focusing mainly on finding the safest dose levels. This is the first time the drug has been tested in humans, so detailed safety information is still being collected. The aim is to assess how well people tolerate the drug and to identify any side effects. It's important to understand that since this is a Phase 1 trial, the main focus is on safety, not efficacy. Thus, there is limited information on its effectiveness at this point.

Overall, NTR-1011 remains in the early testing phase, requiring more information to fully understand its safety in humans. Prospective participants can be assured that researchers are carefully determining the safest dose and closely monitoring for any side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus and rheumatoid arthritis?

Researchers are excited about NTR-1011 because it offers a potentially new way to treat lupus and rheumatoid arthritis. Unlike standard treatments that often involve broad immunosuppressants or anti-inflammatory drugs, NTR-1011 targets specific pathways that may lead to more precise control of inflammation with fewer side effects. The trial is investigating different dosages and delivery methods (subcutaneous and intravenous), which could provide flexibility and improved convenience for patients. By honing in on these innovative approaches, NTR-1011 might offer faster, more effective relief than current options.

What evidence suggests that NTR-1011 might be an effective treatment for lupus and rheumatoid arthritis?

Research shows that NTR-1011 clears harmful substances in the body known as neutrophil extracellular traps (NETs). These NETs are linked to autoimmune diseases like lupus and rheumatoid arthritis. Early results suggest that removing NETs can alter the course of these diseases and may help reduce symptoms. Studies indicate that this method could offer a promising new way to treat autoimmune conditions. In rheumatoid arthritis, similar treatments have effectively reduced inflammation and disease activity. Overall, NTR-1011 targets specific parts of the immune system related to these diseases, making it a potential new treatment. ^{1 3 6 7 8}

Who Is on the Research Team?

Hakop Gevorkyan, MD

Principal Investigator

California Clinical Trials Medical Group

Andreas Reiff, PhD, MD

Principal Investigator

Neutrolis

Are You a Good Fit for This Trial?

This trial is for healthy adults and those with systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). Participants must meet specific health criteria to be included. The study excludes individuals who don't fit the health requirements, but detailed exclusion factors are not provided.

Inclusion Criteria

Body mass index between 17.0 and 30.0 kg/m2

Healthy with no clinically significant findings, as determined by medical evaluation at Screening Visit

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

Exclusion Criteria

Pregnancy, nursing, and/or breastfeeding

Participant has used an investigational drug within 30 days (or 5 half-lives whichever is longer) before the first dose of the study intervention

Participant 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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose Evaluation

Single ascending dose evaluation in healthy volunteers to determine the highest safe and well-tolerated dose

4 weeks

Multiple visits (in-person)

Multiple Dose Assessment

Multiple dose assessment in patients to establish a robust PK and PD baseline and generate initial patient-level evidence

8 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NTR-1011

Trial Overview

The trial tests NTR-1011's safety and how it affects the body in both healthy people and patients with SLE or RA. It involves a randomized, double-blind, placebo-controlled design starting with single doses in healthy volunteers then multiple doses in patients.

How Is the Trial Designed?

Group I: Mid dose SC NHV Experimental Treatment 1 Intervention

middle subcutaneous dosage in normal healthy volunteers

Group II: Mid dose IV NHV Experimental Treatment 1 Intervention

middle intravenous dosage in normal healthy volunteers

Group III: Low dose SC NHV Experimental Treatment 1 Intervention

Lowest subcutaneous dosage in normal healthy volunteers

Group IV: Low dose IV NHV Experimental Treatment 1 Intervention

lowest intravenous dosage in normal healthy volunteers

Group V: High dose SC NHV Experimental Treatment 1 Intervention

Highest subcutaneous dosage SC in normal healthy volunteers

Group VI: High dose IV NHV Experimental Treatment 1 Intervention

highest intravenous dosage in normal healthy volunteers

Group VII: Placebo, IV Placebo Group 1 Intervention

0 mg/kg, IV NHV

Group VIII: Placebo, SC Placebo Group 1 Intervention

0 mg/kg, SC NHV

Who Is Running the Clinical Trial?

Neutrolis

Lead Sponsor

Trials

1

Recruited

50+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07237659?term=lupus

Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and ...

This phase 1a and 1b study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary ...

2.

trial.medpath.com

trial.medpath.com/clinical-trial/b1f873c31793002d/nct07237659-ntr-1011-safety-lupus-erythematosus-rheumatoid-arthritis

Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and ...

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 ...

3.

neutrolis.com

neutrolis.com/press-releases/neutrolis-presented-first-in-human-proof-of-concept-data-validating-dnase1l3-mediated-neutrophil-extracellular-trap-net-clearance-as-a-therapeutic-approach-in-autoimmunity-at-american-college-of-rheumatology-convergence-2025

Neutrolis Presented First-in-Human Proof-of-Concept Data ...

First-in-human data validating direct targeting of NETs as a novel therapeutic approach in autoimmunity and inflammatory diseases.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6481641/

Biologics or tofacitinib for people with rheumatoid arthritis ...

Biologics are highly effective in treating rheumatoid arthritis (RA), however there are few head‐to‐head biologic comparison studies.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5476297/

Neutrophil extracellular traps exacerbate Th1-mediated ...

Neutrophil extracellular traps exacerbate Th1-mediated autoimmune responses in rheumatoid arthritis by promoting DC maturation.

6.

trialstoday.org

trialstoday.org/trial/NCT07237659

Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and ...

The main goals of this study are to determine the safety profile of NTR-1011 across subcutaneous and intravenous dose levels, understand how the ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6608010/

At the Bedside: Neutrophil extracellular traps (NETs) as ...

Neutrophil extracellular traps offer insight into the pathogenesis of autoimmune diseases and provide promise in developing disease markers and novel ...

8.

globenewswire.com

globenewswire.com/news-release/2025/10/29/3176704/0/en/Neutrolis-Presented-First-in-Human-Proof-of-Concept-Data-Validating-DNASE1L3-Mediated-Neutrophil-Extracellular-Trap-NET-Clearance-as-a-Therapeutic-Approach-in-Autoimmunity-at-Ameri.html

Neutrolis Presented First-in-Human Proof-of-Concept Data

First-in-human data validating direct targeting of NETs as a novel therapeutic approach in autoimmunity and inflammatory diseases.