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

Recruiting Phase 1 Interventional Study
Idiopathic Pulmonary Fibrosis (IPF)
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At a Glance
Age
40 – 85
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Mannkind Corporation · Industry
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About 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.

Trial Locations
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Eligibility Criteria
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 no…
Contacts

Donna McKinley

844-446-3561

dmckinley@mannkindcorp.com

CONTACT