Clinical Trial

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

Completed Phase 1
View on ClinicalTrials.gov →
Summary
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.
Protocol Amendment History 5 changes
critical Trial completed 2026-07-23
notable Enrollment increased: 24 -> 27 participants 2026-07-23
notable Trial sites expanded: 5 -> 8 locations 2026-04-14
notable Primary completion pushed: 2026-04-01 -> 2026-06-15 2026-04-14
minor Completion pushed: 2026-04-01 -> 2026-06-15 2026-04-14
Trial Details
NCT Number NCT07344558
Lead Sponsor Mannkind Corporation
Conditions Idiopathic Pulmonary Fibrosis (IPF)
Enrollment 27 participants
Start Date 2025-12-22
Primary Completion 2026-06-17 (estimated)
Study Completion 2026-06-17 (estimated)
Updated on ClinicalTrials.gov 2026-07-22