A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis

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.

Study Overview

• Status: Recruiting
• Conditions: Idiopathic Pulmonary Fibrosis (IPF)
• Intervention / Treatment: Drug: Placebo; Drug: MNKD-201(Nintedanib DPI)

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Donna McKinley; Phone Number: 844-446-3561; Email: dmckinley@mannkindcorp.com

Study Locations

• United States
  • California
    • Fresno, California, United States, 93720
      • Recruiting
      • VALDI
      • Principal Investigator: Vijay Balasubramanian, MD
      • Contact: MacKenzie Moreno; Phone Number: 559-228-6600; Email: mmoreno@themedicalresearchgroup.com
    • Palm Springs, California, United States, 92262
      • Recruiting
      • Palmtree Clinical Research
      • Contact: Daniel Rangel; Phone Number: 760-778-7799; Email: drangel@palmtreeclinical.com
      • Principal Investigator: Ayad Gharghoury, MD
  • Florida
    • Doral, Florida, United States, 33172
      • Recruiting
      • Innova Pharma Research
      • Principal Investigator: Giralt Yanez, MD
      • Contact: Mario Llobet; Email: mllobet@innovapresearch.com
    • Hialeah, Florida, United States, 33012
      • Recruiting
      • New Life Medical Research
      • Contact: Isis Gonzalez; Email: isisg@newlifemedresearch.com
      • Principal Investigator: Armand Bermudez, MD
    • Miami, Florida, United States, 33186
      • Recruiting
      • New Access Research and Medical Services
      • Principal Investigator: Andres Redondo, MD
      • Contact: Beatriz Zozaya; Email: bzozaya@newaccessresearch.com
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Southeastern Research Center
      • Contact: Lauren Miller; Phone Number: 336-659-8414; Email: lmiller@southeasternresearchcenter.com
      • Principal Investigator: Hassan Yousef, MD
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Recruiting
      • Low Country Research
      • Contact: Deena Ranchich; Phone Number: 843-572-8545; Email: dranchich@lowcountry.com
      • Principal Investigator: Thomas Kaelin, DO, FCCP
  • Texas
    • McKinney, Texas, United States, 75069
      • Recruiting
      • Metroplex Pulmomary & Sleep Center
      • Principal Investigator: Shahrukh Kureishy, MD
      • Contact: Rupa Krishna; Phone Number: 972-838-1892; Email: rkrishna@mpsleepcenter.com
    • McKinney, Texas, United States, 75071
      • Recruiting
      • Pulmonary Medicine Consultants
      • Contact: Shahzain Kureishy; Phone Number: 972-542-2186; Email: shahzainmpsc@gmail.com
      • Principal Investigator: Rashid Rahman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Is ≥40 to ≤85 years of age at the time of signing the informed consent form.
2. Diagnosis of IPF
3. Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening.
4. Has FVC >45% 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:

1. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, and bronchiolitis obliterans organizing pneumonia.
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. Recent systemic infection within 4 weeks before the Screening visit or symptomatic viral or bacterial infection at time of Screening.
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 1 month 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 > 6 liters/min at rest.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: MNKD-201(Nintedanib DPI); MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
Experimental: 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	Drug: MNKD-201(Nintedanib DPI); MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
Placebo Comparator: Placebo; Participants will receive matching placebo across both cohorts of the study	Drug: Placebo; The placebo control in this study is an empty cartridge without any powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
(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)	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)	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	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	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	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	Up to Day 7
(Cohort 1) Rate of Study Drug Discontinuations	The within-treatment number and proportion of participants with study drug dose discontinuations	Up to Day 7
(Cohort 2) Rate of Study Drug Discontinuations	The within-treatment number and proportion of participants with study drug dose discontinuations	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	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	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	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	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	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	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	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	Up to Day 7

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the maximum tolerated dose (MTD) of MKND-201 in patients with IPF	MTD within the tested MNKD-201 dose range	Up to Day 7

Collaborators and Investigators

• Sponsor: Mannkind Corporation
• Investigators: Study Director: Wassim Fares, MD, MSc, FCCP, Mannkind Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 2, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nintedanib; dry powder inhalation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: MKC-NI-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: under assessment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No