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NCT07237659 · ClinicalTrials.gov registry record · Phase 1
Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA
A Phase 1 study of SLE (Systemic Lupus) and RA - Rheumatoid Arthritis, sponsored by Neutrolis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT07237659: Recruiting Phase 1 study of SLE (Systemic Lupus) and RA - Rheumatoid Arthritis, sponsored by Neutrolis.
NCT07237659 is a Phase 1 study of SLE (Systemic Lupus) and RA - Rheumatoid Arthritis that is actively recruiting participants, run by Neutrolis. The registered enrollment target is 48 participants, above the 32-participant average among 6 other SLE (Systemic Lupus) trials with a reported enrollment target (50% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07237659, a Phase 1 study of SLE (Systemic Lupus) and RA - Rheumatoid Arthritis, is actively recruiting participants, sponsored by Neutrolis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Incidence of safety and tolerability (DLTs) to inform RP2D
Conditions Studied
Interventions
- DRUG NTR1011
Study Locations (1)
California
- California Clinical Trials Medical Group - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2025-09-04 |
| Est. Completion | 2026-01-07 |
| Phase | Phase 1 |
What NCT07237659 shows while recruiting
NCT07237659 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, above the 32-participant average among 6 other SLE (Systemic Lupus) trials with a reported enrollment target (50% higher).
The record links to 2 conditions, with SLE (Systemic Lupus) appearing as the primary indexed condition, and to 1 intervention - of which NTR1011 is the first listed.
NCT07237659 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07237659 about?
NCT07237659 is a clinical study titled "Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA". 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 t...
What is the current status of trial NCT07237659?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2025-09-04. Estimated completion is 2026-01-07.
What conditions does trial NCT07237659 study?
This clinical trial studies the following conditions: SLE (Systemic Lupus), RA - Rheumatoid Arthritis.
What interventions are being tested in trial NCT07237659?
The interventions under investigation include: NTR1011 (DRUG).
Who is sponsoring clinical trial NCT07237659?
This trial is sponsored by Neutrolis, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07237659 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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