A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
NCT ID: NCT07344558
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2025-12-22
2026-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: MNKD-201 Target Dose or placebo
Participants will receive a target dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation three times daily for 7 days
MNKD-201(Nintenadib DPI)
MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
Cohort 2: MNKD-201 High Dose or placebo
Participants will receive a high dose of MNKD-201 (Nintedanib DPI) or placebo, administered via oral inhalation twice daily for 7 days
MNKD-201(Nintenadib DPI)
MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
Placebo
Participants will receive matching placebo across both cohorts of the study
Placebo
The placebo control in this study is an empty cartridge without any powder.
Interventions
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MNKD-201(Nintenadib DPI)
MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
Placebo
The placebo control in this study is an empty cartridge without any powder.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of IPF
3. Either treatment-naive or is currently on background pirfenidone on a stable dose for at least 3 months prior to Screening.
4. Has FVC \>45% and \<100% of predicted of normal, as determined by the central spirometry reader, during Screening.
5. 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.
6. Has a body weight \>40 kg (\>88 lbs.) at Screening.
7. For female participants of childbearing potential, agreement to use acceptable birth control
8. 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
9. Is capable of performing spirometry, as required by the study procedures and ATS guidelines.
10. CT chest within 2 years of Screening, consistent with an IPF diagnosis, per investigator assessment.
Exclusion Criteria
2. 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.
3. Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion), as determined by the investigator.
4. Significant Cardiovascular diseases
5. Has had a recent or an ongoing systemic infection
6. Prior hospitalization for confirmed coronavirus disease 2019 (COVID-19), acute exacerbation of IPF or any lower respiratory tract infection within 3 months of Screening.
7. Has a history of asthma, with the exception of resolved childhood asthma.
8. Has known obstructive lung disease
9. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 times the upper limit of normal (ULN) during Screening.
10. Advanced liver and kidney function.
11. Current or recent (within 30 days of Screening) use of nintedanib.
12. Use of prednisone ≥10 mg/day within 3 months prior to Screening, or other significant immunosuppression
13. 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.
14. Has participated in another clinical study of a new chemical entity, new device, or a prescription medicine within the 1 month before Screening
15. Current alcohol, medication, or illicit drug abuse
16. 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.
17. Has received a live vaccine within the 3 months prior to the first dose of study drug.
18. 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.
19. Has oxygen requirement of \> 3 liters/min at rest.
40 Years
75 Years
ALL
No
Sponsors
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Mannkind Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Wassim Fares, MD, MSc, FCCP
Role: STUDY_DIRECTOR
Mannkind Corporation
Locations
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VALDI
Fresno, California, United States
Palmtree Clinical Research
Palm Springs, California, United States
Southeastern Research Center
Winston-Salem, North Carolina, United States
Low Country Research
Charleston, South Carolina, United States
Metroplex Pulmomary & Sleep Center
McKinney, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MKC-NI-002
Identifier Type: -
Identifier Source: org_study_id
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