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

NCT07237659 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: NTR1011-001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 1a and 1b study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of NTR-1011 in healthy adults and in adult patients with systemic lupus erythematosus and rheumatoid arthritis. The main goals of this study are to determine the safety profile of NTR-1011 across subcutaneous and intravenous dose levels, understand how the drug behaves in the body, characterize its biological activity through relevant pharmacodynamic markers, assess the potential for immune responses to treatment, and explore early signals of clinical benefit in autoimmune disease settings. This is a randomized, double blind, placebo controlled study that begins with a single ascending dose evaluation in healthy volunteers followed by a multiple dose assessment in patients. The design is intended to define the highest safe and well tolerated dose, establish a robust PK and PD baseline, and generate initial patient level evidence to support dose selection and advancement into subsequent clinical development.

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 (8)

Low dose SC NHV

EXPERIMENTAL

Lowest subcutaneous dosage in normal healthy volunteers

Drug: NTR1011

Mid dose SC NHV

EXPERIMENTAL

middle subcutaneous dosage in normal healthy volunteers

Drug: NTR1011

High dose SC NHV

EXPERIMENTAL

Highest subcutaneous dosage SC in normal healthy volunteers

Drug: NTR1011

Low dose IV NHV

EXPERIMENTAL

lowest intravenous dosage in normal healthy volunteers

Drug: NTR1011

Mid dose IV NHV

EXPERIMENTAL

middle intravenous dosage in normal healthy volunteers

Drug: NTR1011

High dose IV NHV

EXPERIMENTAL

highest intravenous dosage in normal healthy volunteers

Drug: NTR1011

Placebo, IV

PLACEBO COMPARATOR

0 mg/kg, IV NHV

Drug: NTR1011

Placebo, SC

PLACEBO COMPARATOR

0 mg/kg, SC NHV

Drug: NTR1011

Interventions

NTR1011 DRUG

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

High dose IV NHV; High dose SC NHV; Low dose IV NHV; Low dose SC NHV; Mid dose IV NHV; Mid dose SC NHV; Placebo, IV; Placebo, SC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Pregnancy, nursing, and/or breastfeeding.
• The participant has used an investigational drug within 30 days (or 5 half-lives whichever is longer) before the first dose of the study intervention.
• \. Has received any prescription or nonprescription over the counter (except occasional use of acetaminophen, paracetamol, or ibuprofen prior to dosing) medication during the last 14 days. Occasional use is defined at the Investigator's discretion.
• \. Has a positive urine test for drugs of abuse, or cotinine at the Screening Visit, regular consumption of alcohol within 6 months before screening or use of illicit substances within 3 months before the Screening Visit.
• \. Has a positive test for hepatitis B surface antigen, hepatitis C virus and/or human immunodeficiency virus (HIV).
• \. Donation or loss of blood or plasma within 4 weeks before initial dosing.

Sponsors & Collaborators

• Neutrolis: lead

Study Sites (1)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

Location

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

• Hakop Gevorkyan, MD

  California Clinical Trials Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: November 20, 2025
• Study Start: September 4, 2025
• Primary Completion: February 17, 2026
• Study Completion: February 17, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)