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Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
Yes
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years - 55 Years
Gender
All
More Inclusion & Exclusion 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 ≥50% of predicted (using Global Lung Index, GLI 2012,
predicted values) at screening.
- Participants must have DLCO (corrected for hemoglobin ) ≥ 35% of predicted (using
Global Lung Index, GLI 2017, predicted values) at screening.
- Participants must have FEV1 ≥40% 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.
- 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 1
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Agomab Spain S.L.
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Philippe Wiesel, MD
Principal Investigator Affiliation
Agomab Therapeutics
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
United Kingdom
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
IPF
Arms & Interventions
Arms
Experimental: 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)
Placebo Comparator: 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)
Interventions
Drug: - AGMB-447
AGMB-447 inhaled drug
Other: - placebo
placebo inhaled drug
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
Medicines Evaluation Unit, Manchester, United Kingdom