MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis (IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo in patients with IPF.
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.
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.
Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion), as determined by the investigator.
Significant Cardiovascular diseases
Sequential
MNKD-201(Nintedanib DPI)
DrugMNKD-201 is a dry powder nintedanib formulation for oral inhalation.
Placebo
DrugThe placebo control in this study is an empty cartridge without any powder.
(Cohort 1) Events of Bronchospasm
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events \[TEAE\] immediately after inhalation of wheezing or chest tightness)
(Cohort 2) Events of Bronchospasm
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events \[TEAE\] immediately after inhalation of wheezing or chest tightness)
(Cohort 1) Changes in FEV1 (mL) from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
(Cohort 2) Changes in FEV1 (mL) from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
Determine the maximum tolerated dose (MTD) of MKND-201 in patients with IPF
MTD within the tested MNKD-201 dose range
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