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

NCT07237659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

DRUG

NTR1011

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

Sponsors & Collaborators

  • Neutrolis

    lead INDUSTRY

Principal Investigators

  • Andreas Reiff, PhD, MD · Neutrolis

  • Hakop Gevorkyan, MD · California Clinical Trials Medical Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2026-02-17
Completion
2026-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237659 on ClinicalTrials.gov