AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Treatment-emergent adverse events
Frequency and severity of reported treatment-emergent adverse events will be graded per CTCAE 5-point scale
Time frame: Week 24
Pulmonary Function
Change in forced vital (FVC) capacity in liters
Time frame: Week 28
Pharmacodynamics via CSF1
Plasma CSF1 assessment and other exploratory biomarkers
Time frame: Week 28
ST GEORGE'S RESPIRATORY QUESTIONNAIRE IDIOPATHIC PULMONARY FIBROSIS (SGRQ-I)
Change in health-related quality of life, as measured by St. George's Respiratory Questionnaire (SGRQ-I)
Time frame: Week 28
Cmax
Peak Plasma Concentration (Cmax) measurement
Time frame: Week 24
AUC
Area under the plasma concentration versus time curve (AUC) measurement
Time frame: Week 24
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