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Phase 1a/b Study of NTR-1011 for SLE and RA

This study is testing a new treatment called NTR-1011 for adults with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). It's also being tested in healthy adults. The main goals are to find out how safe NTR-1011 is, what dose is best tolerated, and how your body handles it. Researchers also want to see if there are early signs that NTR-1011 might help patients with SLE or RA by reducing inflammation. NTR-1011 works by helping to clear harmful substances called NETs that can build up in these conditions. The healthy volunteer part of the study (Phase 1a) is complete and no longer enrolling. The study plans to enroll 24 participants in total.

Study design
This is a Phase 1a/1b, first-in-human study. The Phase 1a portion, which is complete, was a randomized, double-blind, placebo-controlled study in healthy adults.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and tolerability will be measured for 30 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07237659

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Neutrolis
~24 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:NTR1011

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and tolerability
Measured over 30 days

Conditions

SLE (Systemic Lupus)
RA - Rheumatoid Arthritis

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Where it's being run

7 sites across 1 states
California7

Study leadership

  • Andreas Reiff, PhD, MD · STUDY_CHAIR · Neutrolis

Who to contact

Andreas Reiff, MD, PhD
[email protected]
(626) 264-2734
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

Healthy men and women, 18-55 years of age
Body mass index (BMI) between 17.0 and 30.0 kg/m²
Good general health, confirmed by medical history, physical exam, vital signs, ECG, and lab testing
Willing and able to use highly effective contraception during and after the study
Men and women, 18-75 years of age
Able to understand and sign informed consent, and comply with study visits
Willing and able to use highly effective contraception during and after the study
Diagnosis of SLE for at least 6 months, meeting 2019 EULAR/ACR classification criteria
Active disease at screening
Positive lupus-related antibodies (e.g., anti-dsDNA, anti-Smith) and low complement (C3/C4)
On stable standard-of-care background therapy (e.g., antimalarials, low-dose corticosteroids, and at least one conventional DMARD)
Diagnosis of RA for at least 3 months, meeting 2010 ACR/EULAR classification criteria
Moderate-to-severe active disease
Seropositive for rheumatoid factor and/or anti-CCP antibodies
On stable standard-of-care background therapy (e.g., low-dose corticosteroids and at least one conventional DMARD)

Exclusion

Pregnant or breastfeeding
History of drug allergies or anaphylaxis to human, murine, or yeast proteins, monoclonal antibodies, or other allergens
Use of an investigational drug within 30 days (or 5 half-lives) before dosing
Positive test for hepatitis B, hepatitis C, or HIV
Clinically significant heart, lung, digestive, blood, autoimmune, psychiatric, or other medical condition
Clinically significant abnormal lab values (e.g., liver enzymes, blood counts) or ECG findings
Uncontrolled high blood pressure
Poor venous access
Pregnant or breastfeeding
Known allergy or reaction to NTR-1011, placebo components, or related products
Use of an investigational drug within 30 days (or 5 half-lives) before dosing, or concurrent enrollment in another clinical trial
History of cancer within the past year (with limited exceptions)
Significant kidney impairment, severe liver dysfunction, or severe lung disease
Uncontrolled high blood pressure or significant cardiovascular disease (e.g., recent heart attack or stroke, certain arrhythmias)
Active, recurrent, or high-risk infection, including active or latent tuberculosis without appropriate treatment, opportunistic infections, or chronic hepatitis B
Recent symptoms of COVID-19 without a documented negative test
Receipt of a live vaccine within 4 weeks before screening or planned within 4 weeks after last dose
Significant central nervous system disease or pain-amplification conditions (e.g., epilepsy, fibromyalgia) that could interfere with study assessments
Major surgery within 8 weeks before screening or planned within 6 months after baseline
History of bone marrow, stem cell, or solid organ transplant (except cornea)
Uncontrolled diabetes within the past 12 months (with some exceptions)
History of a blood clot within the past 12 months (with some exceptions)
Clinically significant abnormal lab values (e.g., liver enzymes, blood counts) at screening

What this trial measures

  • Safety and tolerability30 days

    Incidence of safety and tolerability (DLTs) to inform RP2D