A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study of the Safety, Tolerability, and Pharmacokinetics of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
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.
• 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.