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)

Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA (NCT07237659) is a Phase 1 interventional studying SLE (Systemic Lupus) and RA - Rheumatoid Arthritis, sponsored by Neutrolis. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For SLE (Systemic Lupus), a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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 weakened immune system virus (HIV). 5\. Donation or loss of blood or plasma within 4 weeks before initial dosing. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

NTR1011

NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

California Clinical Trials Medical Group

Glendale, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07237659), the sponsor (Neutrolis), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07237659 clinical trial studying?

Who can participate in NCT07237659?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07237659?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07237659. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07237659. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.