Actively Recruiting
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
Led by Mannkind Corporation · Updated on 2026-05-05
24
Participants Needed
9
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 85 years at the time of consent
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- Either treatment-naive or on stable dose of pirfenidone or nerandomilast for at least 3 months before screening
- Forced Vital Capacity (FVC) greater than 45% of predicted normal at screening
- Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for hemoglobin 40% or more of predicted normal within 12 months before screening, or tested at screening if no prior DLCO
- Body weight greater than 40 kg (88 lbs) at screening
- Female participants of childbearing potential agree to use acceptable birth control
- Male participants able to father children agree to use protocol-recommended contraception
- Ability to perform spirometry according to study procedures and guidelines
- Chest CT scan within 2 years before screening consistent with IPF diagnosis as assessed by investigator
You will not qualify if you...
- Known causes of interstitial lung disease other than IPF, such as radiation, sarcoidosis, hypersensitivity pneumonitis, or bronchiolitis obliterans organizing pneumonia
- Diagnosis of any connective tissue disease including scleroderma, polymyositis, lupus, or rheumatoid arthritis
- Major extrapulmonary physiological restrictions like chest wall abnormalities or large pleural effusions
- Significant cardiovascular diseases
- Recent systemic infection within 4 weeks before screening or symptomatic viral/bacterial infection at screening
- Hospitalization for COVID-19, acute IPF exacerbation, or lower respiratory tract infection within 3 months before screening
- History of asthma except resolved childhood asthma
- Known obstructive lung disease
- Elevated liver enzymes (ALT, AST) or bilirubin above 1.5 times the normal limit at screening
- Advanced liver or kidney dysfunction
- Use of nintedanib within 30 days before screening
- Use of prednisone over 10 mg/day within 1 month before screening or significant immunosuppression
- Active lung cancer or cancer requiring chemotherapy or radiation within 3 years, except certain treated skin, prostate, or cervical cancers
- Participation in another clinical trial within 1 month before screening
- Current abuse of alcohol, medications, or illicit drugs
- Blood donation or loss over 400 mL within 3 months before screening
- Live vaccine received within 3 months before first study drug dose
- Smoking any substance including electronic cigarettes or marijuana within 3 months before screening or quitting less than 1 year ago
- Oxygen requirement over 6 liters per minute at rest
AI-Screening
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Trial Site Locations
Total: 9 locations
1
VALDI
Fresno, California, United States, 93720
Actively Recruiting
2
Palmtree Clinical Research
Palm Springs, California, United States, 92262
Actively Recruiting
3
Innova Pharma Research
Doral, Florida, United States, 33172
Actively Recruiting
4
New Life Medical Research
Hialeah, Florida, United States, 33012
Actively Recruiting
5
New Access Research and Medical Services
Miami, Florida, United States, 33186
Actively Recruiting
6
Southeastern Research Center
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
7
Low Country Research
Charleston, South Carolina, United States, 29406
Actively Recruiting
8
Metroplex Pulmomary & Sleep Center
McKinney, Texas, United States, 75069
Actively Recruiting
9
Pulmonary Medicine Consultants
McKinney, Texas, United States, 75071
Actively Recruiting
Research Team
D
Donna McKinley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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