RecruitingPhase 1

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

United States24 participantsStarted 2026-07-15

Plain-language 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)

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability

Timeframe: 30 days

Trial details

NCT IDNCT07237659

SponsorNeutrolis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Andreas Reiff, MD, PhD

(626) 264-2734 reiff@neutrolis.com

View on ClinicalTrials.gov More SLE (Systemic Lupus) trials