IPFPhase 1NCT06181370
Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF
A Phase 1 study testing AGMB-447 in people with IPF, run by Agomab Spain S.L. at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- IPF
- What is being tested?
- AGMB-447
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2023to 29 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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).
Who cannot join
- 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.
Show all 24Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Medicines Evaluation Unit Ltd. an IQVIA business
Manchester, M23 9QZ
About this study
Official title: 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
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
- Being tested
- AGMB-447, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGMB-447Drug
AGMB-447 inhaled drug
placeboOther
placebo inhaled drug
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
To evaluate the safety and tolerability of AGMB-447 in terms of AE at every visit
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From Screening Through Study Completion, up to 8 Weeks
Secondary outcomes (2)
Plasma levels of AGMB-447
To characterize the pharmacokinetics (PK) of AGMB-447 by measuring the amount in plasma
Measured: From Screening Through Study Completion, up to 8 Weeks
Plasma levels of the major metabolite
To characterize the pharmacokinetics (PK) of the major metabolite by measuring the amount in plasma
Measured: From Screening Through Study Completion, up to 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Dec 2023
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agomab Spain S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Wiesel, MD, Study director, Agomab Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181370
- Sponsor's protocol ID
- AGMB-447-C101
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2023
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06181370
- Acronym / sponsor ID
- AGMB-447-C101
- Conditions
- IPF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Agomab Spain S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGMB-447 | Experimental | Drug: AGMB-447Participants 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 | Placebo comparator | Other: placeboParticipants 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) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (24 listed)
- 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:
- 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:
- Clinically significant abnormalities in liver function at screening including any of the following:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGMB-447AGMB-447 inhaled drug | Drug | AGMB-447 |
| placeboplacebo inhaled drug | Other | placebo |
Primary outcome
Number of participants with adverse events
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
2 secondary outcomes
Plasma levels of AGMB-447
Time frame: From Screening Through Study Completion, up to 8 Weeks
Plasma levels of the major metabolite
Time frame: From Screening Through Study Completion, up to 8 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for IPF
Active, not recruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Buloxibutid in People With Idiopathic Pulmonary Fibrosis.
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Progressive Pulmonary Fibrosis (PPF)
Progressive Pulmonary Fibrosis, Interstitial Lung Disease
RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Wiesel, MD study director
Agomab Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AGMB-447 in people with IPF, run by Agomab Spain S.L. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: From Screening Through Study Completion, up to 8 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.