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

NCT07237659 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: NTR1011-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 7

Brief 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)

Conditions

SLE (Systemic Lupus); RA - Rheumatoid Arthritis

Keywords

LIBERATE-I; Neutrolis; DNase1L3 fusion protein; DNase1L3 analogue

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Incidence of safety and tolerability (DLTs) to inform RP2D

  30 days

Study Arms (1)

starting dose IV Patient

EXPERIMENTAL

expected enzymatically and pharmacologically active IV dose in human SLE and RA patients

Drug: NTR1011

Interventions

NTR1011 DRUG

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

starting dose IV Patient

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• 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)

Sponsors & Collaborators

• Neutrolis: lead

Study Sites (7)

Carewell Arthritis Center

Apple Valley, California, 92307, United States

RECRUITING

Attune Health Research Inc

Beverly Hills, California, 90211, United States

RECRUITING

Covina Arthritis Clinic

Covina, California, 91722, United States

RECRUITING

Novamed

Monterey Park, California, 91752, United States

RECRUITING

Southland Arthritis Clinic

Riverside, California, 92508, United States

RECRUITING

Southland Arthritis Clinic

Temecula, California, 92592, United States

RECRUITING

Foothill Arthritis Clinic

Tujunga, California, 91042, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Andreas Reiff, PhD, MD

  Neutrolis

  STUDY CHAIR

Central Study Contacts

Andreas Reiff, MD, PhD

CONTACT

(626) 264-2734; reiff@neutrolis.com

Ken Olivier, PhD

CONTACT

617-949-1575; olivier@neutrolis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase 1b, open-label study in adult patients with moderate-to-severe SLE and RA

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 20, 2025
• Study Start: July 15, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)