A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis

Prior treatment

• Recent systemic infection within 4 weeks before the Screening visit or symptomatic viral or bacterial infection at time of Screening.
• Prior hospitalization for confirmed coronavirus disease 2019 (COVID-19), acute exacerbation of IPF or any lower respiratory tract infection within 3 months of Screening.
• Use of prednisone \>10 mg/day within 1 month prior to Screening, or other significant immunosuppression
• Has participated in another clinical study of a new chemical entity, new device, or a prescription medicine within the 1 month before Screening
• Current alcohol, medication, or illicit drug abuse
• Has lost more than 400 mL blood, e.g., as a blood donor, or donor of blood products, during the 3 months prior to Screening.
• Has received a live vaccine within the 3 months prior to the first dose of study drug.
• Smokes (any substance including electronic cigarettes and marijuana) within 3 months prior to Screening or is an ex-cigarette smoker who gave up \<1 year ago.

Other illness

• Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, and bronchiolitis obliterans organizing pneumonia.
• Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis, regardless of whether or not it is presumed to be related to their pulmonary fibrosis diagnosis.
• Significant Cardiovascular diseases
• Has a history of asthma, with the exception of resolved childhood asthma.
• Has known obstructive lung disease
• Active lung cancer (primary or metastatic) or any cancer requiring chemotherapy or radiation therapy within 3 years, except appropriately treated non-melanoma skin cancer, localized non-malignant prostate cancer, or in situ carcinoma of uterine cervix.

Lab values

• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 times the upper limit of normal (ULN) during Screening.

Other

• Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion), as determined by the investigator.
• Advanced liver and kidney function.
• Current or recent (within 30 days of Screening) use of nintedanib.
• Has oxygen requirement of \> 6 liters/min at rest.

• Is ≥40 to ≤85 years of age at the time of signing the informed consent form.
• Diagnosis of IPF
• Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening.
• Has FVC \>45% of predicted of normal, as determined by the central spirometry reader, during Screening.
• DLCO corrected for hemoglobin \[Visit 1\] ≥40% of predicted of normal, within 12 months of Screening. If no historical DLCO is available prior to Screening, this is to be done during Screening and read locally.
• Has a body weight \>40 kg (\>88 lbs.) at Screening.
• For female participants of childbearing potential, agreement to use acceptable birth control
• For male participants who can father a child and are having intercourse with females of childbearing potential, agreement to use a protocol-recommended method of contraception
• Is capable of performing spirometry, as required by the study procedures and ATS guidelines.
• CT chest within 2 years of Screening, consistent with an IPF diagnosis, per investigator assessment.