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Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF

NCT06181370 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2025-12-31

No results posted yet for this study

Summary

The purpose of this study is to measure the safety, tolerability PK and PD of inhaled AGMB-477 compared with placebo in healthy participants and participants with IPF. This is an integrated phase 1, single center, 3-part, double-blind, randomized, placebo-controlled SAD (Part A) and MAD (Part B) study in healthy participants and multiple dose study in IPF participants (Part C).

Safety, tolerability PK and PD will be assessed following single ascending, multiple ascending and multiple dosing of AGMB-447 administered via nebulizer in Part A, B and C, respectively.

Conditions

Interventions

DRUG

AGMB-447

AGMB-447 inhaled drug

OTHER

placebo

placebo inhaled drug

Sponsors & Collaborators

  • Agomab Spain S.L.

    lead INDUSTRY

Principal Investigators

  • Philippe Wiesel, MD · Agomab Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT06181370 on ClinicalTrials.gov