Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF

Exclusion Criteria

• •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.
• •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.