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RecruitingPhase 1

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Physical exams, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Up to 24 participants with moderate-to-severe SLE or RA will: * Receive five weekly doses of NTR-1011 given directly into a vein (intravenous) * Continue their current standard-of-care treatment throughout the study * Be monitored for 4 weeks after their last dose * Be assigned to either the SLE group or the RA group (up to 12 patients each)"
  • "Assessments Across both portions, safety is assessed through physical examinations, laboratory testing, vital signs, and monitoring for adverse events, including hypersensitivity reactions as an adverse event of special interest."
  • "Blood samples are collected at scheduled visits to measure drug levels (PK), NET-related biomarkers (PD, including cell-free DNA measures and calprotectin), and antibodies against NTR-1011 (immunogenicity)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of NTR-1011 and looks for early signs that it may help adults with lupus (SLE) or rheumatoid arthritis (RA). The healthy volunteer part is finished; the current part is enrolling adults with moderate-to-severe SLE or RA. Everyone gets five weekly doses into a vein while continuing their usual treatment, with checks for 4 weeks after the last dose.

The goal of this clinical trial is to inform the safety and tolerability of NTR-1011 in treating adult patients diagnosed with systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). It will also learn about the safety of NTR-1011 in healthy adult volunteers. The main questions it aims to answer are: * What is the highest dose of NTR-1011 that is safe and well tolerated, when given under the skin or into a vein? * How does the body process NTR-1011, and how does NTR-1011 affect the body? * Does the body develop an immune response to NTR-1011? * Are there early signs that NTR-1011 may benefit patients with SLE or RA when added to their current standard-of-care treatment? In the first part of the study (Phase 1a, now complete), researchers compared single doses of NTR-1011 to a placebo (a look-alike substance that contains no drug) in 48 healthy volunteers to see how the body tolerates and processes the drug. In the current part of the study (Phase 1b, actively recruiting), all participants receive NTR-1011 in addition to their usual SLE or RA treatment; there is no placebo group. Up to 24 participants with moderate-to-severe SLE or RA will: * Receive five weekly doses of NTR-1011 given directly into a vein (intravenous) * Continue their current standard-of-care treatment throughout the study * Be monitored for 4 weeks after their last dose * Be assigned to either the SLE group or the RA group (up to 12 patients each)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • For the current part: Be 18–75 years old.
  • Be able to understand and sign the consent form and attend study visits.
  • Be willing and able to use highly effective birth control during and after the study.
  • For SLE: Have lupus for at least 6 months and meet the study’s diagnosis rules.
  • For SLE: Have active disease, positive lupus antibody tests, and low levels of certain immune proteins.
  • For SLE: Be on stable usual treatment and be up to date on vaccines for your age.
  • For RA: Have rheumatoid arthritis for at least 3 months, meet the study’s diagnosis rules, and have moderate-to-severe active disease with positive RA antibody tests.
  • For RA: Be on stable usual treatment, including at least one standard medicine that slows the disease.

Who can't join

  • Be pregnant or breastfeeding, or have a known allergy or reaction to NTR-1011, placebo ingredients, or related products.
  • Have recently used an experimental drug, or be taking part in another clinical trial.
  • Have had cancer in the past year, or a bone marrow, stem cell, or organ transplant other than a cornea transplant. Some cancer exceptions apply.
  • Have serious kidney, liver, lung, or heart disease; uncontrolled high blood pressure; or important abnormal blood test results.
  • Have an active, repeated, or high-risk infection, including tuberculosis without proper treatment or long-term hepatitis B; or recent COVID-19 symptoms without a recorded negative test.
  • Have received a live vaccine within 4 weeks before screening, or plan one within 4 weeks after the last dose.
  • Have a brain or nerve condition, or a condition that increases pain, that could affect study checks; or have major surgery within the study’s restricted times.
  • Have had uncontrolled diabetes or a blood clot within the past 12 months. Some exceptions apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Phase 1a - Healthy Volunteers (Completed, No Longer Enrolling) Key Inclusion Criteria * 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 Key Exclusion Criteria * 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 Phase 1b - Adult Patients with SLE and RA (Actively Recruiting) General Inclusion Criteria (All Patients) * 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 Additional Inclusion Criteria - SLE Patients * 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) * Up to date on age-appropriate vaccinations Additional Inclusion Criteria - RA Patients * 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) Key Exclusion Criteria (All Patients) * 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

Study sites (7)

CA