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

Part of paid clinical trials in Apple Valley, California.

Sponsor
Neutrolis
Study ID
NCT07237659
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • RA - Rheumatoid Arthritis
  • SLE (Systemic Lupus)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • NTR1011 — DRUG
    NTR-1011 will be presented as a solution for intravenous (IV) administration.

Study Details

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)

Key Dates

First listed
Nov 20, 2025
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: starting dose IV Patient
    expected enzymatically and pharmacologically active IV dose in human SLE and RA patients

Primary Outcome Measure

Safety and tolerability [ Time Frame: 30 days ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Carewell Arthritis CenterApple ValleyCalifornia92307
Diraj Karmani, MD
909-581-8477
Attune Health Research IncBeverly HillsCalifornia90211
Swamy Venuturupalli, MD
310-652-0010
Covina Arthritis ClinicCovinaCalifornia91722
Samy Metyas, MD
[email protected]
626-966-1909
NovamedMonterey ParkCalifornia91752
Soha Dolatabadi, MD
213-266-8200
Southland Arthritis ClinicRiversideCalifornia92508
Amal Mehta, MD
951-924-6500
Southland Arthritis ClinicTemeculaCalifornia92592
Amal Mehta, MD
714-244-2279
Foothill Arthritis ClinicTujungaCalifornia91042
Dan La, MD
213-281-5146

Find similar trials in Apple Valley, CA

By research site
Carewell Arthritis Center· Apple Valley, CAAttune Health Research Inc· Beverly Hills, CACovina Arthritis Clinic· Covina, CANovamed· Monterey Park, CASouthland Arthritis Clinic· Riverside, CASouthland Arthritis Clinic· Temecula, CA

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