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

NCT07344558 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-05

No results posted yet for this study

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)

Interventions

DRUG

MNKD-201(Nintedanib DPI)

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Wassim Fares, MD, MSc, FCCP · Mannkind Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2026-06-15
Completion
2026-06-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07344558 on ClinicalTrials.gov