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

NCT06181370 | Recruiting Phase 1

• 1 other identifier: AGMB-447-C101
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

IPF

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events

  To evaluate the safety and tolerability of AGMB-447 in terms of AE at every visit

  From Screening Through Study Completion, up to 8 Weeks

• Number of participants with abnormal clinical laboratory values

  To evaluate the safety and tolerability of AGMB-129 in terms of abnormal laboratory parameters at every visit

  From Screening Through Study Completion, up to 8 Weeks

• Number of participants with abnormal ECG parameters

  To evaluate the safety and tolerability of AGMB-447 in terms of abnormal ECGs at every visit

  From Screening Through Study Completion, up to 8 Weeks

• Number of participants with abnormal vital signs

  To evaluate the safety and tolerability of AGMB-447 in terms of vital signs at every visit

  From Screening Through Study Completion, up to 8 Weeks

• Number of participants with abnormal physical exams

  To evaluate the safety and tolerability of AGMB-447 in terms of physical exams at every visit

  From Screening Through Study Completion, up to 8 Weeks

• Number of participants with abnormal spirometry parameters

  To evaluate the safety and tolerability of AGMB-447 in terms of spirometry at every visit

  From Screening Through Study Completion, up to 8 Weeks

Secondary Outcomes (2)

• Plasma levels of AGMB-447

  From Screening Through Study Completion, up to 8 Weeks

• Plasma levels of the major metabolite

  From Screening Through Study Completion, up to 8 Weeks

Study Arms (2)

AGMB-447

EXPERIMENTAL

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)

Drug: AGMB-447

placebo

PLACEBO COMPARATOR

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)

Other: placebo

Interventions

AGMB-447 DRUG

AGMB-447 inhaled drug

AGMB-447

placebo OTHER

placebo inhaled drug

placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants aged between 18-55 years inclusive, at the time of informed consent.
• Participants must have FEV1 ≥80% predicted at screening and prior to randomization on Day -1 or Day 1 of treatment period 1 (using Global Lung Index, GLI 2012, predicted values).
• Participant must have a body weight of at least 50.0 kg and BMI ≥ 18 and ≤ 32 kg/m2 at screening.
• Participants must be in good health as determined by medical history, physical examination, vital signs, 12-lead ECG, spirometry and clinical laboratory assessments at the time of screening, as judged by the Investigator.
• Male and female participants aged \>40 years inclusive, at the time of informed consent.
• Participants must have a confirmed diagnosis of IPF (IPF based on 2022 ATS/ERS/JRS/ALAT Guidelines) as confirmed by the Investigator based on chest High Resolution Computed Tomography Scan taken within 5 years of screening and, only if available, surgical lung biopsy)
• Participants must be either:
• Receiving a stable, well tolerated dose of Nintedanib for 3 months prior to screening for the treatment of IPF
• Receiving no current antifibrotic medication for the treatment of IPF. This includes those who have never received treatment and those who have stopped medication due to intolerance for any reason, except non-responsiveness, for at least 6 weeks prior to screening.
• Participants must have FVC ≥40% of predicted (using Global Lung Index, GLI 2012, predicted values) at screening.
• Participants must have DLCO (corrected for hemoglobin ) ≥ 25% of predicted (using Global Lung Index, GLI 2017, predicted values) at screening.
• Participants must have FEV1 ≥30% predicted at screening and prior to randomization on Day -1 or Day 1 (using Global Lung Index, GLI 2012, predicted values).

You may not qualify if:

• History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical study or expose the participant to undue risk as judged by the Investigator.
• After a minimum of 10 minutes supine rest at the time of screening or prior to randomization on Day -1 or Day 1 of treatment period 1:
• Systolic blood pressure \<90 or \>150 mmHg, or
• Diastolic blood pressure \<50 or \>95 mmHg, or
• Pulse \<40 or \>90 bpm
• Any clinically significant abnormalities in resting ECG at the time of screening or prior to randomization on Day -1 or Day 1 of treatment period 1 including prolonged QTcF (\>450 ms for males; \>470 ms for females using the mean of triplicate ECG's) and cardiac arrhythmias, as judged by the Investigator.
• Clinically significant abnormalities in renal function at screening including any of the following:
• Serum creatinine \>2 x ULN
• eGFR \<80 mL/min
• Clinically significant abnormalities in liver function at screening including any of the following:
• Bilirubin \>1.5 x ULN
• Aminotransferases \>2 x ULN
• ALP \>1.5 x ULN
• History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical study or expose the participant to undue risk as judged by the Investigator.
• History or presence of any clinically significant pulmonary abnormalities, with the exception of IPF, in the opinion of the Investigator.

Sponsors & Collaborators

• Agomab Spain S.L.: lead

Study Sites (1)

Medicines Evaluation Unit Ltd. an IQVIA business

Manchester, M23 9QZ, United Kingdom

RECRUITING

Study Officials

• Philippe Wiesel, MD

  Agomab Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Tim Van Kaem

CONTACT

0032 3318 91 70; clinicalstudies@agomab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 26, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)