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

Part of paid clinical trials in Fresno, California.

Sponsor
Mannkind Corporation
Study ID
NCT07344558
Phase
PHASE1
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Eligibility Criteria

Sex
ALL
Age
40 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • MNKD-201(Nintedanib DPI) — DRUG
    MNKD-201 is a dry powder nintedanib formulation for oral inhalation.
  • Placebo — DRUG
    The placebo control in this study is an empty cartridge without any powder.

Study Details

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.

Key Dates

Start date
Dec 22, 2025
Status verified
May 2026
Primary completion
Jun 15, 2026
Completion
Jun 15, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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
  • 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
  • Placebo Comparator: Placebo
    Participants will receive matching placebo across both cohorts of the study

Primary Outcome Measure

(Cohort 1) Events of Bronchospasm [ Time Frame: Up to Day 7 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
VALDIFresnoCalifornia93720
MacKenzie Moreno
[email protected]
559-228-6600
Vijay Balasubramanian, MD (PRINCIPAL_INVESTIGATOR)
Palmtree Clinical ResearchPalm SpringsCalifornia92262
Daniel Rangel
[email protected]
760-778-7799
Ayad Gharghoury, MD (PRINCIPAL_INVESTIGATOR)
Innova Pharma ResearchDoralFlorida33172
Mario Llobet
[email protected]
Giralt Yanez, MD (PRINCIPAL_INVESTIGATOR)
New Life Medical ResearchHialeahFlorida33012
Isis Gonzalez
[email protected]
Armand Bermudez, MD (PRINCIPAL_INVESTIGATOR)
New Access Research and Medical ServicesMiamiFlorida33186
Beatriz Zozaya
[email protected]
Andres Redondo, MD (PRINCIPAL_INVESTIGATOR)
Southeastern Research CenterWinston-SalemNorth Carolina27103
Lauren Miller
[email protected]
336-659-8414
Hassan Yousef, MD (PRINCIPAL_INVESTIGATOR)
Low Country ResearchCharlestonSouth Carolina29406
Deena Ranchich
[email protected]
843-572-8545
Thomas Kaelin, DO, FCCP (PRINCIPAL_INVESTIGATOR)
Metroplex Pulmomary & Sleep CenterMcKinneyTexas75069
Rupa Krishna
[email protected]
972-838-1892
Shahrukh Kureishy, MD (PRINCIPAL_INVESTIGATOR)
Pulmonary Medicine ConsultantsMcKinneyTexas75071
Shahzain Kureishy
[email protected]
972-542-2186
Rashid Rahman, MD (PRINCIPAL_INVESTIGATOR)

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VALDI· Fresno, CAPalmtree Clinical Research· Palm Springs, CAInnova Pharma Research· Doral, FLNew Life Medical Research· Hialeah, FLNew Access Research and Medical Services· Miami, FLSoutheastern Research Center· Winston-Salem, NC

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