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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
143
AGMB-447 inhaled drug
placebo inhaled drug
Medicines Evaluation Unit Ltd. an IQVIA business
Manchester, United Kingdom
Number of participants with adverse events
To evaluate the safety and tolerability of AGMB-447 in terms of AE at every visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From Screening Through Study Completion, up to 8 Weeks
Plasma levels of AGMB-447
To characterize the pharmacokinetics (PK) of AGMB-447 by measuring the amount in plasma
Time frame: 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
Time frame: From Screening Through Study Completion, up to 8 Weeks
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