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)
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)
• 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
⁃ 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)