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

NCT07344558 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MKC-NI-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Keywords

Nintedanib; dry powder inhalation

Outcome Measures

Primary Outcomes (16)

• (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 Outcomes (1)

• Determine the maximum tolerated dose (MTD) of MKND-201 in patients with IPF

  Up to Day 7

Study Arms (3)

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

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

Drug: MNKD-201(Nintedanib DPI)

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo across both cohorts of the study

Drug: Placebo

Interventions

Placebo DRUG

The placebo control in this study is an empty cartridge without any powder.

Placebo

MNKD-201(Nintedanib DPI) DRUG

MNKD-201 is a dry powder nintedanib formulation for oral inhalation.

Cohort 1: MNKD-201 Target Dose or placebo; Cohort 2: MNKD-201 High Dose or placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (9)

VALDI

Fresno, California, 93720, United States

RECRUITING

Palmtree Clinical Research

Palm Springs, California, 92262, United States

RECRUITING

Innova Pharma Research

Doral, Florida, 33172, United States

RECRUITING

New Life Medical Research

Hialeah, Florida, 33012, United States

RECRUITING

New Access Research and Medical Services

Miami, Florida, 33186, United States

RECRUITING

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Low Country Research

Charleston, South Carolina, 29406, United States

RECRUITING

Metroplex Pulmomary & Sleep Center

McKinney, Texas, 75069, United States

RECRUITING

Pulmonary Medicine Consultants

McKinney, Texas, 75071, United States

RECRUITING

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Wassim Fares, MD, MSc, FCCP

  Mannkind Corporation

  STUDY DIRECTOR

Central Study Contacts

Donna McKinley

CONTACT

844-446-3561; dmckinley@mannkindcorp.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 15, 2026
• Study Start: December 22, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)