Mannkind Corporation
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.
Inclusion Criteria: 1. Is ≥40 to ≤85 years of age at the time of signing the informed consent form. 2. Diagnosis of IPF 3. Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening. 4. Has FVC \>45% of predicted of normal, as determined by the central spirometry reader, during Screening. 5. 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. 6. Has a body…
MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
The placebo control in this study is an empty cartridge without any powder.