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A First-in-Human Safety Trial of MTX-474

NCT06535841 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-05-18

No results posted yet for this study

Summary

A randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and PK of single and multiple ascending doses of MTX-474 administered in healthy adults.

Conditions

  • Healthy

Interventions

BIOLOGICAL

MTX-474

MTX-474 is an immunoglobin G1 (IgG1) monoclonal antibody directed against Ephrin B2 that binds to and has demonstrated ability to block phosphorylation of its preferred receptor EphB4. Increased levels of circulating soluble EphrinB2 have been found in patients with systemic sclerosis.

OTHER

Placebo

Matching Placebo - Normal Saline

Sponsors & Collaborators

  • Mediar Therapeutics

    lead INDUSTRY

Principal Investigators

  • Jeffrey Bornstein, MD · Mediar Therapeutics

  • Gloria Wong, PhD, MBBS · Nucleus Network Brisbane

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-04-24
Completion
2025-04-24

Countries

  • Australia

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 NCT06535841 on ClinicalTrials.gov