MNKD-201 for Idiopathic Pulmonary Fibrosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Wassim Fares, MD, MSc, FCCP
Principal Investigator
Mannkind Corporation
Are You a Good Fit for This Trial?
This trial is for people aged 40-75 with Idiopathic Pulmonary Fibrosis. They must have a certain lung function level, weigh over 88 lbs, and be able to perform required breathing tests. Women of childbearing age and men who can father children must agree to use birth control. Participants can be treatment-naive or on stable pirfenidone.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive MNKD-201 or placebo via oral inhalation for 7 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MNKD-201
Trial Overview
The study is testing MNKD-201 (a form of nintedanib) against a placebo in patients with IPF. It's a Phase 1b trial focusing on how safe the drug is, how well it's tolerated, and what happens to it inside the body after inhalation compared to no active treatment.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive a high dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation twice daily for 7 days
Participants will receive a target dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation three times daily for 7 days
Participants will receive matching placebo across both cohorts of the study
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mannkind Corporation
Lead Sponsor
Michael E. Castagna
Mannkind Corporation
Chief Executive Officer since 2017
PharmD from Massachusetts College of Pharmacy & Sciences, MBA from The Wharton School of Business at the University of Pennsylvania
Burkhard Blank
Mannkind Corporation
Chief Medical Officer since 2021
MD
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