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A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

NCT05349760 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-01-19

No results posted yet for this study

Summary

AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.

Conditions

Interventions

BIOLOGICAL

AMB-05X

A fully human monoclonal immunoglobulin (IgG2) directed against c-fms

DRUG

Placebo

Saline/D5W

Sponsors & Collaborators

  • AmMax Bio, Inc.

    lead INDUSTRY

Principal Investigators

  • Dorothy Nguyen, MD · AmMax Bio, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2025-03-31
Completion
2025-06-30
FDA Drug
Yes

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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 NCT05349760 on ClinicalTrials.gov