Assessing the safety and tolerability of AGMB-447 in healthy individuals and those 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

This study is testing a new inhaled medication called AGMB-447 to see if it's safe and well-tolerated in healthy people and those with idiopathic pulmonary fibrosis (IPF).

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Agomab Therapeutics NV (Industry-sponsored)
• Locations: 1 site (Manchester)
• Trial ID: NCT06181370 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of inhaled AGMB-447 compared to a placebo in both healthy participants and individuals diagnosed with idiopathic pulmonary fibrosis (IPF). It is a Phase I, single-center, double-blind, randomized, placebo-controlled study consisting of three parts: single ascending doses (Part A), multiple ascending doses (Part B) in healthy participants, and multiple dosing in IPF participants (Part C). Participants will receive AGMB-447 via nebulizer, and various assessments will be conducted to monitor safety and drug effects.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18-55 and individuals over 40 with a confirmed diagnosis of IPF.

Not a fit: Patients with severe comorbidities or those not meeting the eligibility criteria for health and age may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with IPF, potentially improving their quality of life.

How similar studies have performed: While this approach is novel, similar studies assessing inhaled therapies for IPF have shown promise in the past.

Eligibility 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 this trial is running

Manchester

• Medicines Evaluation Unit Ltd. an IQVIA business — Manchester, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Tim Van Kaem

Conditions IPF