Actively Recruiting
Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF
Led by Agomab Spain S.L. · Updated on 2025-12-31
145
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 55 years for healthy participants
- Healthy participants must have FEV1 at least 80% predicted
- Healthy participants must weigh at least 50 kg with BMI between 18 and 32 kg/m2
- Healthy participants must be in good health based on medical history, physical exam, vital signs, ECG, spirometry, and lab tests
- Male or female aged over 40 years for IPF participants
- IPF participants must have confirmed diagnosis of IPF by chest CT scan or lung biopsy
- IPF participants must be on stable dose of Nintedanib for 3 months or not receiving antifibrotic medication for at least 6 weeks
- IPF participants must have FVC at least 40% predicted
- IPF participants must have DLCO at least 25% predicted
- IPF participants must have FEV1 at least 30% predicted
You will not qualify if you...
- Any clinically relevant acute or chronic medical or psychiatric condition posing risk or interfering with safety
- Blood pressure outside 90-150 mmHg systolic or 50-95 mmHg diastolic after 10 minutes resting for healthy participants
- Pulse outside 40-90 bpm after 10 minutes resting for healthy participants
- Significant ECG abnormalities including prolonged QTcF or arrhythmias
- Significant renal impairment including serum creatinine over 2 times upper limit or eGFR under 80 mL/min
- Significant liver abnormalities including bilirubin over 1.5 times upper limit, aminotransferases over 2 times upper limit, or ALP over 1.5 times upper limit
- For IPF participants, any significant lung abnormalities aside from IPF or airway obstruction with pre-bronchodilator FEV1/FVC less than 0.7
- Acute IPF exacerbation within 3 months prior to screening
- Respiratory tract infection within 4 weeks prior to dosing
- Malignancy within 5 years except non-invasive basal cell carcinoma or benign colonic polyps
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medicines Evaluation Unit Ltd. an IQVIA business
Manchester, United Kingdom, M23 9QZ
Actively Recruiting
Research Team
T
Tim Van Kaem
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here