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A First-in-Human Safety Trial of MTX-463

NCT06401213 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-01-17

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-463 administered in healthy adults.

Conditions

  • Healthy

Interventions

BIOLOGICAL

MTX-463

MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases and malignancies.

OTHER

Placebo

Matching Placebo-- Normal Saline

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Mediar Therapeutics

    lead INDUSTRY

Principal Investigators

  • Ahad Sabet, MD · ICON plc

  • Jeffrey Bornstein, MD · Mediar Therapeutics

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
2024-04-15
Primary Completion
2024-11-15
Completion
2024-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT06401213 on ClinicalTrials.gov