RecruitingPhase 1NCT07237659

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)


Sponsor

Neutrolis

Enrollment

24 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing the safety and tolerability of a new drug called NTR-1011 in healthy adults first, and then in adults with lupus (SLE) or rheumatoid arthritis (RA) — two autoimmune diseases where the immune system attacks the body's own tissues. **You may be eligible if...** - You are between 18 and 55 years old - For the healthy volunteer group: you are in good health with no significant medical conditions - Your BMI is between 17.0 and 30.0 - You are willing to follow all study requirements **You may NOT be eligible if...** - You are pregnant, nursing, or breastfeeding - You have taken an experimental drug recently - You have significant health conditions (for healthy volunteers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNTR1011

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


Locations(7)

Carewell Arthritis Center

Apple Valley, California, United States

Attune Health Research Inc

Beverly Hills, California, United States

Covina Arthritis Clinic

Covina, California, United States

Novamed

Monterey Park, California, United States

Southland Arthritis Clinic

Riverside, California, United States

Southland Arthritis Clinic

Temecula, California, United States

Foothill Arthritis Clinic

Tujunga, California, United States

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NCT07237659


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