NCT06181370

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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of Inhaled AGMB-447 in Healthy Participants and Participants With Idiopathic Pulmonary Fibrosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (estimated)
• Sponsor: Agomab Spain S.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• IPF

Interventions

Type	Name	Description
DRUG	AGMB-447	AGMB-447 inhaled drug
OTHER	placebo	placebo inhaled drug

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-12-26
• Last updated: 2025-12-31

Locations

1 site across 1 country: United Kingdom