Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA
NCT ID: NCT07237659
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2025-09-04
2026-01-07
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose SC NHV
Lowest subcutaneous dosage in normal healthy volunteers
NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Mid dose SC NHV
middle subcutaneous dosage in normal healthy volunteers
NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
High dose SC NHV
Highest subcutaneous dosage SC in normal healthy volunteers
NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Low dose IV NHV
lowest intravenous dosage in normal healthy volunteers
NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Mid dose IV NHV
middle intravenous dosage in normal healthy volunteers
NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
High dose IV NHV
highest intravenous dosage in normal healthy volunteers
NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Placebo, IV
0 mg/kg, IV NHV
NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Placebo, SC
0 mg/kg, SC NHV
NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Interventions
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NTR1011
NTR-1011 will be presented as a solution for subcutaneous (SC) and intravenous (IV) administration.
Eligibility Criteria
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Exclusion Criteria
2. 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.
2\. 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.
3\. 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.
4\. Has a positive test for hepatitis B surface antigen, hepatitis C virus and/or human immunodeficiency virus (HIV).
5\. Donation or loss of blood or plasma within 4 weeks before initial dosing.
18 Years
75 Years
ALL
Yes
Sponsors
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Neutrolis
INDUSTRY
Responsible Party
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Principal Investigators
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Andreas Reiff, PhD, MD
Role: STUDY_CHAIR
Neutrolis
Hakop Gevorkyan, MD
Role: PRINCIPAL_INVESTIGATOR
California Clinical Trials Medical Group
Locations
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California Clinical Trials Medical Group
Glendale, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NTR1011-001
Identifier Type: -
Identifier Source: org_study_id
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