Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Safety, Tolerability, and Pharmacokinetics of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
Led by Mannkind Corporation · Updated on 2026-05-05
24
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MNKD-201 (Nintedanib dry powder inhalation) in patients with Idiopathic Pulmonary Fibrosis (IPF) through a Phase 1b randomized, double-blind, placebo-controlled study. The main goal is to assess the safety, tolerability, and how the drug behaves in the body compared to a placebo. This study is important to understand the effects of MNKD-201 when inhaled by patients with IPF. Participants will be assigned to receive either a target dose or a high dose of MNKD-201 or a matching placebo. The target dose group receives the inhaled powder three times daily for 7 days, while the high dose group receives it twice daily for 7 days. Those in the placebo groups receive an empty inhalation cartridge without any powder. The study includes two cohorts based on dosing schedules. During the trial, participants undergo lung function tests such as forced expiratory volume and forced vital capacity to monitor any changes from before to after dosing. Researchers will watch for bronchospasm events, study drug discontinuations, dose reductions, and adverse events up to 7 days. The study also aims to determine the highest dose of MNKD-201 that patients can tolerate. Total participation time aligns with the 7-day treatment and monitoring period.
CONDITIONS
Brief 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 a stable dose of pirfenidone or nerandomilast for at least 3 months prior to screening
- Forced vital capacity (FVC) greater than 45% of predicted normal during screening
- Diffusing capacity for carbon monoxide (DLCO) corrected for hemoglobin at least 40% of predicted within 12 months prior or at screening
- Body weight greater than 40 kg (88 lbs) at screening
- Agreement to use acceptable birth control for females of childbearing potential
- Agreement to use protocol-recommended contraception for males who can father a child
- Ability to perform spirometry as required by study procedures
- Chest CT consistent with IPF diagnosis within 2 years of screening per investigator assessment
You will not qualify if you...
- Known causes of interstitial lung disease other than IPF (e.g., radiation, sarcoidosis, hypersensitivity pneumonitis)
- Diagnosis of connective tissue diseases such as scleroderma, polymyositis, lupus, or rheumatoid arthritis
- Major extrapulmonary physiological restrictions such as chest wall abnormalities or large pleural effusion
- 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 infection within 3 months of screening
- History of asthma except resolved childhood asthma
- Known obstructive lung disease
- Elevated liver enzymes or bilirubin greater than 1.5 times upper limit of normal
- Advanced liver or kidney dysfunction
- Current or recent (within 30 days) use of nintedanib
- Use of prednisone over 10 mg/day within 1 month prior to screening or significant immunosuppression
- Active lung cancer or cancer requiring chemotherapy or radiation within 3 years
- Participation in another clinical study within 1 month before screening
- Current abuse of alcohol, medication, or illicit drugs
- Blood loss over 400 mL in the 3 months before screening
- Receipt of live vaccine within 3 months before first study dose
- Smoking any substance including e-cigarettes or marijuana within 3 months prior or recent ex-smoker under 1 year
- Oxygen requirement exceeding 6 liters per minute at rest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants receive MNKD-201 or placebo via oral inhalation either three times daily or twice daily for 7 days depending on cohort assignment.
Daily visits or assessments during the 7-day dosing period
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here