IPF
Conditions
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.
Interventions
DRUGAGMB-447
AGMB-447 inhaled drug
OTHERplacebo
placebo inhaled drug
Sponsors
Agomab Spain S.L.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Contacts
STUDY_DIRECTORPhilippe Wiesel, MD
Agomab Therapeutics
Outcome results
None listed