Idiopathic Pulmonary Fibrosis (IPF)Phase 1NCT07344558
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 1 study testing MNKD-201(Nintedanib DPI) in people with Idiopathic Pulmonary Fibrosis (IPF), run by Mannkind Corporation at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- MNKD-201(Nintedanib DPI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 9 sitesUnited States
- Study dates
- 22 Dec 2025to 17 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Is capable of performing spirometry, as required by the study procedures and ATS guidelines.
- CT chest within 2 years of Screening, consistent with an IPF diagnosis, per investigator assessment.
Who cannot join
- 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.
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- Has a history of asthma, with the exception of resolved childhood asthma.
- Has known obstructive lung disease
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5 times the upper limit of normal (ULN) during Screening.
- Advanced liver and kidney function.
- Current or recent (within 30 days of Screening) use of nintedanib.
- Use of prednisone >10 mg/day within 1 month prior to Screening, or other significant immunosuppression
- Active lung cancer (primary or metastatic) or any cancer requiring chemotherapy or radiation therapy within 3 years, except appropriately treated non-melanoma skin cancer, localized non-malignant prostate cancer, or in situ carcinoma of uterine cervix.
- Has participated in another clinical study of a new chemical entity, new device, or a prescription medicine within the 1 month before Screening
- Current alcohol, medication, or illicit drug abuse
- Has lost more than 400 mL blood, e.g., as a blood donor, or donor of blood products, during the 3 months prior to Screening.
- Has received a live vaccine within the 3 months prior to the first dose of study drug.
- Smokes (any substance including electronic cigarettes and marijuana) within 3 months prior to Screening or is an ex-cigarette smoker who gave up <1 year ago.
- Has oxygen requirement of > 6 liters/min at rest.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Low Country Research
Charleston, South Carolina, 29406
Innova Pharma Research
Doral, Florida, 33172
VALDI
Fresno, California, 93720
New Life Medical Research
Hialeah, Florida, 33012
Metroplex Pulmomary & Sleep Center
McKinney, Texas, 75069
Pulmonary Medicine Consultants
McKinney, Texas, 75071
New Access Research and Medical Services
Miami, Florida, 33186
Palmtree Clinical Research
Palm Springs, California, 92262
Southeastern Research Center
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study of the Safety, Tolerability, and Pharmacokinetics of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
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
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- MNKD-201(Nintedanib DPI), Placebo
- Keywords
- Nintedanib, dry powder inhalation
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNKD-201(Nintedanib DPI)Drug
MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
PlaceboDrug
The placebo control in this study is an empty cartridge without any powder.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: MNKD-201 Target Dose or placebo | Experimental | Participants will receive a target dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation three times daily for 7 days Receives: Drug: MNKD-201(Nintedanib DPI) |
| Cohort 2: MNKD-201 High Dose or placebo | Experimental | Participants will receive a high dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation twice daily for 7 days Receives: Drug: MNKD-201(Nintedanib DPI) |
| Placebo | Placebo comparator | Participants will receive matching placebo across both cohorts of the study Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Cohort 1) Events of Bronchospasm
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events [TEAE] immediately after inhalation of wheezing or chest tightness)
Measured: Up to Day 7
(Cohort 2) Events of Bronchospasm
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events [TEAE] immediately after inhalation of wheezing or chest tightness)
Measured: Up to Day 7
(Cohort 1) Changes in FEV1 (mL) from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
Measured: Up to Day 7
(Cohort 2) Changes in FEV1 (mL) from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
Measured: Up to Day 7
(Cohort 1) Changes in FEV1 / FVC ratio from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1/FVC ratio from pre-dose to any time post-dose
Measured: Up to Day 7
(Cohort 2) Changes in FEV1 / FVC ratio from pre-dose to post-dose
The within-treatment number and proportion of participants with changes in FEV1/FVC ratio from pre-dose to any time post-dose
Measured: Up to Day 7
(Cohort 1) Rate of Study Drug Discontinuations
The within-treatment number and proportion of participants with study drug dose discontinuations
Measured: Up to Day 7
(Cohort 2) Rate of Study Drug Discontinuations
The within-treatment number and proportion of participants with study drug dose discontinuations
Measured: Up to Day 7
(Cohort 1) Rate of Study Drug Dose Reductions
The within-treatment number and proportion of participants with study drug dose reductions
Measured: Up to Day 7
(Cohort 2) Rate of Study Drug Dose Reductions
The within-treatment number and proportion of participants with study drug dose reductions
Measured: Up to Day 7
(Cohort 1) Rate of Treatment Emergent Adverse Events (TEAEs)
The within-treatment number and proportion of participants with TEAEs overall and by severity, relationship to study drug, and outcome
Measured: Up to Day 7
(Cohort 2) Rate of Treatment Emergent Adverse Events (TEAEs)
The within-treatment number and proportion of participants with TEAEs overall and by severity, relationship to study drug, and outcome
Measured: Up to Day 7
(Cohort 1) Rate of Treatment Related Adverse Events (TRAEs)
The within-treatment number and proportion of participants with TRAEs overall and by severity and outcome
Measured: Up to Day 7
(Cohort 2) Rate of Treatment Related Adverse Events (TRAEs)
The within-treatment number and proportion of participants with TRAEs overall and by severity and outcome
Measured: Up to Day 7
(Cohort 1) Rate of Serious Adverse Events (SAEs)
The within-treatment number and proportion of participants with SAEs overall and by severity, relationship to study drug, and outcome
Measured: Up to Day 7
(Cohort 2) Rate of Serious Adverse Events (SAEs)
The within-treatment number and proportion of participants with SAEs overall and by severity, relationship to study drug, and outcome
Measured: Up to Day 7
Secondary outcomes (1)
Determine the maximum tolerated dose (MTD) of MKND-201 in patients with IPF
MTD within the tested MNKD-201 dose range
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start22 Dec 2025
- Primary completion17 Jun 2026
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mannkind Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wassim Fares, MD, MSc, FCCP, Study director, Mannkind Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344558
- Sponsor's protocol ID
- MKC-NI-002
- Status last verified
- Jul 2026
- First submitted
- 7 Jan 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase 1b Clinical Study of the Safety, Tolerability, and Pharmacokinetics of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07344558
- Acronym / sponsor ID
- MKC-NI-002
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Nintedanib, dry powder inhalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mannkind CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 Dec 2025 (actual)
- Primary completion
- 17 Jun 2026 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: MNKD-201 Target Dose or placebo | Experimental | Drug: MNKD-201(Nintedanib DPI)Participants will receive a target dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation three times daily for 7 days |
| Cohort 2: MNKD-201 High Dose or placebo | Experimental | Drug: MNKD-201(Nintedanib DPI)Participants will receive a high dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation twice daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo across both cohorts of the study |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNKD-201(Nintedanib DPI)MNKD-201 is a dry powder nintedanib formulation for oral inhalation. | Drug | Cohort 1: MNKD-201 Target Dose or placebo, Cohort 2: MNKD-201 High Dose or placebo |
| PlaceboThe placebo control in this study is an empty cartridge without any powder. | Drug | Placebo |
Primary outcome
(Cohort 1) Events of Bronchospasm
Time frame: Up to Day 7
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events [TEAE] immediately after inhalation of wheezing or chest tightness)
(Cohort 2) Events of Bronchospasm
Time frame: Up to Day 7
The within-treatment number and proportion of participants with events of bronchospasm (e.g., treatment emergent adverse events [TEAE] immediately after inhalation of wheezing or chest tightness)
(Cohort 1) Changes in FEV1 (mL) from pre-dose to post-dose
Time frame: Up to Day 7
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
(Cohort 2) Changes in FEV1 (mL) from pre-dose to post-dose
Time frame: Up to Day 7
The within-treatment number and proportion of participants with changes in FEV1 from pre-dose to any time post-dose
(Cohort 1) Changes in FEV1 / FVC ratio from pre-dose to post-dose
Time frame: Up to Day 7
The within-treatment number and proportion of participants with changes in FEV1/FVC ratio from pre-dose to any time post-dose
(Cohort 2) Changes in FEV1 / FVC ratio from pre-dose to post-dose
Time frame: Up to Day 7
The within-treatment number and proportion of participants with changes in FEV1/FVC ratio from pre-dose to any time post-dose
(Cohort 1) Rate of Study Drug Discontinuations
Time frame: Up to Day 7
The within-treatment number and proportion of participants with study drug dose discontinuations
(Cohort 2) Rate of Study Drug Discontinuations
Time frame: Up to Day 7
The within-treatment number and proportion of participants with study drug dose discontinuations
(Cohort 1) Rate of Study Drug Dose Reductions
Time frame: Up to Day 7
The within-treatment number and proportion of participants with study drug dose reductions
(Cohort 2) Rate of Study Drug Dose Reductions
Time frame: Up to Day 7
The within-treatment number and proportion of participants with study drug dose reductions
(Cohort 1) Rate of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 7
The within-treatment number and proportion of participants with TEAEs overall and by severity, relationship to study drug, and outcome
(Cohort 2) Rate of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 7
The within-treatment number and proportion of participants with TEAEs overall and by severity, relationship to study drug, and outcome
(Cohort 1) Rate of Treatment Related Adverse Events (TRAEs)
Time frame: Up to Day 7
The within-treatment number and proportion of participants with TRAEs overall and by severity and outcome
(Cohort 2) Rate of Treatment Related Adverse Events (TRAEs)
Time frame: Up to Day 7
The within-treatment number and proportion of participants with TRAEs overall and by severity and outcome
(Cohort 1) Rate of Serious Adverse Events (SAEs)
Time frame: Up to Day 7
The within-treatment number and proportion of participants with SAEs overall and by severity, relationship to study drug, and outcome
(Cohort 2) Rate of Serious Adverse Events (SAEs)
Time frame: Up to Day 7
The within-treatment number and proportion of participants with SAEs overall and by severity, relationship to study drug, and outcome
1 secondary outcome
Determine the maximum tolerated dose (MTD) of MKND-201 in patients with IPF
Time frame: Up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wassim Fares, MD, MSc, FCCP study director
Mannkind Corporation
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MNKD-201(Nintedanib DPI) in people with Idiopathic Pulmonary Fibrosis (IPF), run by Mannkind Corporation at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Cohort 1) Events of Bronchospasm (time frame: Up to Day 7). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.