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

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