A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopa… (NCT07344558) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
United States27 participantsStarted 2025-12-22
Plain-language 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.
Who can participate
Age range
40 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Is ≥40 to ≤85 years of age at the time of signing the informed consent form.
. Diagnosis of IPF
. Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening.
. Has FVC \>45% of predicted of normal, as determined by the central spirometry reader, during Screening.
. DLCO corrected for hemoglobin \[Visit 1\] ≥40% of predicted of normal, within 12 months of Screening. If no historical DLCO is available prior to Screening, this is to be done during Screening and read locally.
. Has a body weight \>40 kg (\>88 lbs.) at Screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
(Cohort 1) Events of Bronchospasm
Timeframe: Up to Day 7
2
(Cohort 2) Events of Bronchospasm
Timeframe: Up to Day 7
3
(Cohort 1) Changes in FEV1 (mL) from pre-dose to post-dose
Timeframe: Up to Day 7
4
(Cohort 2) Changes in FEV1 (mL) from pre-dose to post-dose
Timeframe: Up to Day 7
5
(Cohort 1) Changes in FEV1 / FVC ratio from pre-dose to post-dose
Timeframe: Up to Day 7
6
(Cohort 2) Changes in FEV1 / FVC ratio from pre-dose to post-dose
. For female participants of childbearing potential, agreement to use acceptable birth control
. For male participants who can father a child and are having intercourse with females of childbearing potential, agreement to use a protocol-recommended method of contraception
Exclusion criteria
. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, and bronchiolitis obliterans organizing pneumonia.
. Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis, regardless of whether or not it is presumed to be related to their pulmonary fibrosis diagnosis.
. Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion), as determined by the investigator.
. Significant Cardiovascular diseases
. Recent systemic infection within 4 weeks before the Screening visit or symptomatic viral or bacterial infection at time of Screening.
. Prior hospitalization for confirmed coronavirus disease 2019 (COVID-19), acute exacerbation of IPF or any lower respiratory tract infection within 3 months of Screening.
. Has a history of asthma, with the exception of resolved childhood asthma.
. Has known obstructive lung disease
(Cohort 2) Rate of Study Drug Discontinuations
Timeframe: Up to Day 7
9
(Cohort 1) Rate of Study Drug Dose Reductions
Timeframe: Up to Day 7
10
(Cohort 2) Rate of Study Drug Dose Reductions
Timeframe: Up to Day 7
11
(Cohort 1) Rate of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to Day 7
12
(Cohort 2) Rate of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Up to Day 7
13
(Cohort 1) Rate of Treatment Related Adverse Events (TRAEs)
Timeframe: Up to Day 7
14
(Cohort 2) Rate of Treatment Related Adverse Events (TRAEs)