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A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
Sponsor: Mannkind Corporation
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2025-12-22
Completion Date
2026-06-15
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
MNKD-201(Nintedanib DPI)
MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
Placebo
The placebo control in this study is an empty cartridge without any powder.
Locations (9)
VALDI
Fresno, California, United States
Palmtree Clinical Research
Palm Springs, California, United States
Innova Pharma Research
Doral, Florida, United States
New Life Medical Research
Hialeah, Florida, United States
New Access Research and Medical Services
Miami, Florida, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Low Country Research
Charleston, South Carolina, United States
Metroplex Pulmomary & Sleep Center
McKinney, Texas, United States
Pulmonary Medicine Consultants
McKinney, Texas, United States