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Study finishedPhase1

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

Sponsor: Agomab Spain S.L.

NCT ID: NCT06181370

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AGMB-447 (drug), placebo (other)
How long the study runs
Study runs about 28 months (dates as stated)
About the drug or intervention
AGMB-447 — drug: AGMB-447 inhaled drug · placebo — other: placebo inhaled drug
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 55 Years
Who
All
Number of participants
143
Started
2023-12-01
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for ipf
  • • Phase1 - 143 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 55 Years
  • • Diagnosed with ipf

Where?

  • • Manchester - Medicines Evaluation Unit Ltd. an IQVIA business

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

IPF

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 55 Years
  • Who can join: All genders

Biomarkers mentioned

eGFR

Treatment history

Treatments you must have had:

  • ✓ FEV1 ≥80% predicted at screening and
  • ✓ a body weight of at least 50
  • ✓ FVC ≥40% of predicted (using Global Lung Index, GLI 2012, predicted values) at screening
  • ✓ FEV1 ≥30% predicted at screening and

What the study is looking for

  • ✓Inclusion criteria for Healthy Participants (Parts A and B):
  • ✓Male and female participants aged between 18-55 years inclusive, at the time of agreement to take part.
  • ✓Participants must have FEV1 ≥80% predicted at screening and prior to randomization on Day -1 or Day 1 of treatment...
  • ✓Participant must have a body weight of at least 50.0 kg and BMI ≥ 18 and ≤ 32 kg/m2 at screening.
  • ✓Inclusion Criteria for IPF Participants (Part C)
See the full criteria
Inclusion criteria for Healthy Participants (Parts A and B): * 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. Inclusion Criteria for IPF Participants (Part C) * 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 * OR * 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). Exclusion criteria for Healthy Participants (Parts A and B) * 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 Exclusion Criteria for IPF Participants (Part C) * 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. * Relevant airways obstruction (pre-bronchodilator FEV1/ FVC \< 0.7) at screening. * Any clinically significant abnormalities in resting ECG at the time of screening or prior to randomization on Day -1 or Day 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 liver function at screening including any of the following: * Bilirubin \>1.5 x ULN * Aminotransferases \>2 x ULN * ALP \>1.5 x ULN * Acute IPF exacerbation within 3 months prior to screening and/or during the screening period prior to dose on Day 1 as determined by the Investigator. * Any signs of respiratory tract infection within 4 weeks of screening or prior to dosing on Day 1 that is deemed clinically significant in the opinion of the Investigator. * Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma or resected benign colonic polyps.

Where Is This Study? (1 UK site)

Medicines Evaluation Unit Ltd. an IQVIA business

Manchester M23 9QZ, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-06