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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (1 UK site)
Medicines Evaluation Unit Ltd. an IQVIA business
Manchester M23 9QZ, United Kingdom
