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

Phase 1

Recruiting

• Conditions: IPF
• Interventions: Other: placebo; Drug: AGMB-447

• Registration Number: NCT06181370
• Lead Sponsor: Agomab Spain S.L.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2023-12-26
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Participants will receive a single dose of placebo (part A), multiple doses of placebo over 7 days (part B) or multiple doses of placebo over 14 days (part C)
AGMB-447	AGMB-447	Participants will receive a single dose of AGMB-447 (part A), multiple doses of AGMB-447 over 7 days (part B) or multiple doses of AGMB-447 over 14 days (part C)

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormal physical exams	From Screening Through Study Completion, up to 8 Weeks	To evaluate the safety and tolerability of AGMB-447 in terms of physical exams at every visit
Number of participants with abnormal clinical laboratory values	From Screening Through Study Completion, up to 8 Weeks	To evaluate the safety and tolerability of AGMB-129 in terms of abnormal laboratory parameters at every visit
Number of participants with abnormal ECG parameters	From Screening Through Study Completion, up to 8 Weeks	To evaluate the safety and tolerability of AGMB-447 in terms of abnormal ECGs at every visit
Number of participants with abnormal spirometry parameters	From Screening Through Study Completion, up to 8 Weeks	To evaluate the safety and tolerability of AGMB-447 in terms of spirometry at every visit
Number of participants with adverse events	From Screening Through Study Completion, up to 8 Weeks	To evaluate the safety and tolerability of AGMB-447 in terms of AE at every visit
Number of participants with abnormal vital signs	From Screening Through Study Completion, up to 8 Weeks	To evaluate the safety and tolerability of AGMB-447 in terms of vital signs at every visit

Secondary Outcome Measures

Name	Time	Method
Plasma levels of AGMB-447	From Screening Through Study Completion, up to 8 Weeks	To characterize the pharmacokinetics (PK) of AGMB-447 by measuring the amount in plasma
Plasma levels of the major metabolite	From Screening Through Study Completion, up to 8 Weeks	To characterize the pharmacokinetics (PK) of the major metabolite by measuring the amount in plasma

Trial Locations

Locations (1)

Medicines Evaluation Unit; 🇬🇧 Manchester, United Kingdom